NIH | National Cancer Institute | NCI Wiki  

Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

...

Multiexcerpt

...

MultiExcerptName

...

UserProfiles-NCI

Some significant examples of collaborations and

...

use of EVS resources and services are briefly outlined

...

in this section covering NCI,

...

and in later sections covering NIH,

...

government and standards organizations, and other

...

organizations in the cancer research and biomedical community. This section includes the following NCI profiles:

Table of Contents
minLevel2

...

NCI Division of Cancer

...

Biology (

...

DCB)

Cancer Therapy Evaluation Program (CTEP)

The Cancer Therapy Evaluation Program (CTEP) has had many and sustained collaborations with EVS from 1999 onwards, including:

  • Harmonization and use of NCIt drug and molecular target information in CTEP systems.
  • Harmonization and integration of CTEP disease classification with NCIt, PDQ and MedDRA in NCIm.
  • Joint development, together with other partners, of the redesigned Common Terminology Criteria for Adverse Events (CTCAE) v.4, which has been widely adopted since its release in 2010. (See the detailed description in the Example Case Studies section below.)

The Cancer Diagnosis Program (CDP) - Diagnostics Evaluation Branch

  • EVS is supporting gene nomenclature used in a new CDP Biomarker project, including updating HUGO in the EVS servers so it is accessible to CDP curators.
  • In an extension to this project, EVS will be creating gene and protein sequence variations in the NCIt, according to HGVS guidelines, for genes/proteins of therapeutic interest as requested by CDP. The initial request is 150 genes (in progress), with about 180 protein variants, 300 gene variants, 300 fusion genes, and 300 fusion proteins.
  • This work is to support creation of an application to retrieve content from the NIH Clinical Trial Database into the NCI Clinical Trials Reporting Program (CTRP), and is being done jointly with DCTD, NCI/OCE, NCI/CCR and NIH/NLM.

NCI DCTD and Division of Cancer Prevention (DCP)

EVS staff provides terminology support for the Community Clinical Oncology Program (CCOP), including concepts for use in coding four (4) major clinical trials involving 85,000 patients. An estimated total of 500 studies use NCI Thesaurus terminology.

NCI Division of Cancer Prevention (DCP)

DCP has used EVS, and worked consistently with EVS, since 2002, including the following collaborations and uses:

  • Use of NCIt agent information in DCP systems.
  • Joint work on improved coverage of nutritional and other preventive agents.
  • Joint work in wider working groups and other initiatives to harmonize broader NCI agent coding practices.

CI Office of Communications and Education (OCE)

OCE has been a partner in EVS since 1999, providing much of the seed terminology and development effort for NCIt, and contributing to and using EVS in many ways, including:

  • NCIt drug information used in the PDQ clinical trials database.
  • NCI Drug Dictionary: NCI Thesaurus provides original definitions for the drugs presented in this tool, with about 40,000 visitors monthly (see section 3).
  • NCIt terminology for cancers and related conditions, procedures, and chemotherapy regimens, involving many years of development and harmonization between PDQ and NCIt terminology.
  • NCI Glossary includes lay definitions for key cancer terms, and is incorporated into NCI Thesaurus.

NCI Division of Cancer Control and Population Sciences (DCCPS)

DCCPS collaboration includes several terminology projects related to cancer classification, drugs, chemotherapy regimens, and statistics. DCCPS is currently launching a new initiative on standardized terminology for population health data collection.

NCI Division of Extramural Activities (DEA)

DEA is supported by EVS, which helps collect, develop and map grant-related terminology, including representing NCI in the NIH Research, Condition and Disease Categorization (RCDC) effort.

Other NCI

NCI Supported Cooperative Human Tissue Bank (CHTB): EVS has supported terminology creation and editing for this network of research institutions, which host NCI funded tissue facilities and services providing remnant human tissue and fluids from routine procedures to investigators (NCI, Vanderbilt, U. Penn, UAB School of Medicine, Nationwide Children's Hospital, Ohio State, University of Virginia) There is active use by 14 academic and research organizations and eight (8) commercial organizations. EVS staff assisted with matching up terminology used by these groups to NCIt terminology, creating new NCIt concepts and definitions as needed.

Cancer Central Clinical Database (C3D): EVS provides support for C3D, largely through providing the new and updated terminology and definitions for case report forms. C3D currently supports electronic submission of clinical trials data to the NCI Clinical Data System (CDS) and the Clinical Trials Monitoring Service (CTMS/Theradex).

OPEN (Oncology Patient Enrollment Network): This web-based registration system for patient enrollments onto NCI-sponsored Cooperative Group clinical trials is a highly active project; most terminology supplied for this is standard demographic terminology.

PMA-DCCPS Grant Coding: EVS has worked with DCCPS for a number of years to include in NCIt more than 1,500 concepts for grant coding for DCCPS's Portfolio Management Application. PMA terms are also inserted and appear in the NCI Metathesaurus as a separate terminology.

Common Terminology Criteria for Adverse Events (CTCAE): CTCAE is used throughout the entire oncology community as the standard classification and severity grading scale for adverse events in cancer therapy clinical trials and other oncology settings. It is also used in a number of non-oncology trials and settings.

Version 4, released in May 2009, is a major update based on extensive international participation by stakeholders and experts. It is harmonized with MedDRA at the Adverse Event (AE) level, includes revised AE terms and severity indicators to reflect clinical effects identified with current oncology interventions, and is a caBIG® vocabulary standard. This version is used by more than 50 academic and research organizations, as well as many commercial and non-profit organizations. Five different Apple applications utilize the NCI Thesaurus version of the CTCAE data, and cite NCIt as the source.

CTCAE is designed to integrate into information networks for safety data exchange, and is expected to have a significant impact in data management for AE data collection, analysis, and patient outcomes associated with cancer research and care. EVS played a central role in designing and managing this effort, working closely with CTEP, DCP, VCDE, the Vocabulary Knowledge Center, and many participants from the broader community. The revision was developed and deployed using various EVS tools including the BiomedGT Wiki, Protégé editing tools, LexEVS terminology server, NCI Term Browser, and the EVS ftp site .

caBIG®

caMOD

This database, which predates caBIG®, provides curated information for animal models of human cancers. caMOD annotates information with NCIt terminology, and uses the LexEVS API directly to generate anatomy and diagnosis tree hierarchies. 400 concepts were added or updated for caMOD in the past six months.

ICR (Integrative Cancer Research) Nanotechnology Working Group

caNanoLab has a goal of semantic interoperability across centers performing nanoparticle characterization studies. caNanoLab is based on an information model representing nanoparticles and their physical and in vitro characterization.

EVS provides assistance in curating concept definitions with the community, making them available in NCIt; a glossary of these terms also is provided within the caNanoLab application. (Funding for additional development was recently lost, but caNanoLab continues to be used.) The Nanotechnology Working Group includes about 60 people representing approximately 40 agencies, universities and institutes, a few from Europe. caNanolab is heavily used, representing substantial use of EVS effort. It currently contains 886 samples, 72 sample sources, 3,329 characterizations, and 41 protocols, and identifies 1,073 publications. The caNanoLab homepage shows 141,668 visitors since June 3, 2010. (See also additional nanotechnology-related detail below.)

Georgetown University

Georgetown uses LexEVS and other EVS resources for its cancer Bench-to-Bedside (caB2B) project and other activities. A local LexEVS installation, and NCI's production LexEVS servers, provide terminology support for this project. This is an example of how terminology services are being incorporated into other tools as primary components in support of translational medicine.

Washington University

Washington University uses LexEVS and EVS terminology content in its clinical data warehouse project (CIDER). Washington University deployed LexEVS in 2008 as the terminology server for CIDER. The terminologies are used to code data and for information retrieval. This is an example of an academic medical center adopting NCI EVS technology to support research and clinical enterprise infrastructure.

Ohio State University Medical Center

Ohio State is using LexEVS, NCIt, and NCIm, notably for openMDR. Ohio State University launched openMDR (open metadata repository) in 2009, using local instances of LexEVS, BioPortal, and caDSR. This is an example of an academic research group adopting several open source components of NCI's EVS and semantic infrastructure, and integrating them to create a novel tool for metadata management.

University of Pittsburgh

Pittsburgh uses the NCI Thesaurus cancer, anatomy, and pathology findings terminologies for their research and informatics projects. The ODIE project is used by the University of Pittsburgh, University of California, San Diego, and Children's Hospital, Boston. This collaboration has resulted in the publication of two papers in peer-reviewed journals so far:

  1. Tobias J, Chilukuri R, Komatsoulis GA, Mohantry S, Sioutos N, et al: The CAP Cancer Protocols-A Case Study of caCORE Based Data Standards Implementation to Integrate with the Cancer Biomedical Informatics Grid. BMC Medical Informatics Decision Making, 20; 6:25, 2006.
  2. Liu K, Chapman WW, Savova G, Chute CG, Sioutos N, Crowley RS:Effectiveness of Lexico-syntactic Pattern Matching for Ontology Enrichment with Clinical Documents. Methods Inf Med. 2010: 8;49(6).
Human Studies Database (HSDB) Consortium

HSDB is using LexEVS as a core component of its collaborative, distributed, clinical research systems. The OCRe Terminology is served through an NCBO site, which uses LexEVS. This is an example of a consortium of institutions leveraging LexEVS terminology services at the core of a new workflow for the collection of human studies data.

Common Biorepository Model (CBM)

EVS has provided about 1,300 concepts for this model through support for caDSR. CBM is used in many domains including clinical trials management, ICR, in vivo imaging, and tissue banks and pathology tools.

NIH*

National Library of Medicine (NLM)

Since its inception, EVS has worked with NLM on a variety of terminology content and technology efforts. EVS licenses content from and harmonizes with NLM's Unified Medical Language System (UMLS), building NCIm by modifying and extending a subset of the UMLS Metathesaurus and using NLM editing software.

NCI is also a contributor to the UMLS, for example, providing monthly builds of NCIt for inclusion in UMLS. (UMLS only publishes twice yearly; they pull whichever build is most current at the time they begin processing.) EVS also worked with NLM and other federal partners to develop the Federal Medication Terminologies framework for harmonized medication coding (see below). EVS staff provided startup phrase dictionaries and search criteria for the PubMed Cancer Subset, and jointly maintains this content with NLM on an ongoing basis.

NLM's DailyMed gets over 10 million hits each month, and each of the SPL files in DailyMed uses terminology that is maintained by NCI. There are over 27,000 SPL files on DailyMed, and another 5,000 SPL files that are not on DailyMed. Each of these SPL files requires NCIt codes.

NCI and National Human Genome Research Institute (NHGRI)

The Cancer Genome Atlas (TCGA) is a joint effort between NCI and NHGRI, developing a database of the changes that occur in the genome, associated with a specific cancer type. TCGA creates a national network of research and technology teams, and provides a mechanism for pooling results; data are publically available. 25 Studies are associated with this data, and data are being actively submitted or used by 16 academic and research organizations, 27 commercial organizations, and 17 non-profit organizations. EVS supports terminology for annotating the CDEs for tagging information and samples, mainly cell and specimen type, with information about tumor size, anatomic location, sample preparation, and patient demographics.

National Heart, Lung, and Blood Institute (NHLBI)

Since 2005, NHLBI and EVS have jointly developed terminology in NCIt for various projects including bone marrow transplant clinical trials and the Family Blood Pressure Program. Duke, through an NIH Roadmap project, the American College of Cardiology, and CDISC, have also collaborated with EVS to produce several cardiovascular data standard sets now in use at NHLBI, with a portion incorporated into CDISC SDTM.

National Institute of Child Health and Human Development (NICHD)

Since 2009, NICHD and EVS have jointly developed terminology in NCIt for pediatric terminology, including standardizing data for newborn screening forms, through the Pediatric Terminology Harmonization Initiative, developed to assist Pediatric clinical researchers. This is associated with 848 NICHD Clinical Trials, and is being used by 52 different academic and research organizations.

National Institute of Dental and Craniofacial Research (NIDCR)_*

Since 2008, NIDCR and EVS have jointly developed terminology in NCIt for dental treatments and medical procedures.

NIH Biomedical Translational Research Information System (BTRIS)

Collaboration includes planned EVS publication of the BTRIS Research Entities Dictionary (RED) in support of NIH researchers' coding, retrieval, and analysis of clinical research data stored in BTRIS. RED began with NCIt as a foundation.

NIH Grants

NCIt is one of four NIH-approved terminologies for grant coding, and EVS has helped develop the Research, Condition and Disease Categorization (RCDC) grant coding system.

EVS Partnerships and External Adoption

NCI EVS has extensive external partnerships to develop terminology standards, content, technology, and operational support, greatly broadening the base of adoption and having a major impact on the wider biomedical community.

U.S. Food and Drug Administration (FDA)

FDA has worked with EVS since 2001, with formal Memoranda of Understanding starting in 2004, to develop and harmonize terminology content, standards and systems in areas of mutual interest such as drugs, devices, patient safety, and clinical trials. FDA has chosen EVS and NCIt for developing and publishing many important terminology sets; some 15,000 FDA terms in over 20 defined subsets are now maintained in NCIt and required for regulatory reporting and other purposes. These include:

  • Structured Product Labeling (SPL): Standard terminology for Drug Establishment Registration (Regulated Product Submission), Drug Listing and the Content of Labels. 16 NCIt subsets used for submission of proposed labeling by all manufacturers using electronic formats. There are 9,466 establishments from over 100 countries that use the SPL terminology in order to comply with federal regulations to list their products. There are approximately 40,000 subscribers to the FDA's SPL listserv, and this is one of the primary mechanisms to inform users of changes to the SPL terminology that is maintained by NCI. FDA does not track the number of hits against http://www.fda.gov/ForIndustry/DataStandards/default.htm and its sub pages, but they suspect that the number of hits is very high; when firms do not select the correct NCIt code, their submitted SPL file will not pass validation.
  • CDRH Device Event Problem Codes: NCIt subsets used for the reporting of medical device problems to FDA. CDRH is responsible for ensuring the safety and effectiveness of medical devices and eliminating unnecessary human exposure to man-made radiation from medical, occupational and consumer products. Approximately 200 organizations from some 3,000 different reporting locations report to the CDRH using NCI Thesaurus terminology. CDRH receives approximately 35,000 submissions per month that are based on NCI Thesaurus terminology.
  • Individual Case Safety Report (ICSR): NCIt subsets used for adverse event reporting. Proposed regulations for electronic submissions will create similar levels of use for these subsets.
  • eCTD (electronic Common Technical Documents): Standard terminology for regulatory forms required by the Center for Drug Evaluation and Research (CDER).
  • Drug Submissions: Beginning June 1, 2009, FDA no longer accepts paper submissions for drug establishment registration and listing unless a waiver is granted. Moving from a paper-based format to an electronic system will improve the timeliness and accuracy of the submissions. This is not possible without the terminology provided by NCI Thesaurus. Of 22,246 New Drug related Submissions from October 2009 - September 2010, (63%) were in electronic format submissions that required terminology from NCI Thesaurus.
  • Stability: NCIt provides terminology for FDA and HL7 Stability Data Standards, including human pharmaceuticals, animal drugs and medical devices that are in regulatory submissions, amendments, supplements and annual reports.

(For more information, visit the NCI website.

Clinical Data Interchange Standards Consortium (CDISC)

All CDISC controlled terminology – more than 9,800 terms – is maintained and published as NCIt subsets, as part of a partnership started in 2002 to develop and support global data standards for medical research. This includes four main terminology efforts:

  • Study Data Tabulation Model (SDTM): An approved standard for FDA submissions, SDTM has been downloaded more than 14,000 times in over 60 countries, primarily for institutional use. More than 270 commercial organizations use SDTM, as do numerous academic, non-profit and research organizations.
  • Clinical Data Acquisition Standards Harmonization (CDASH) is developing clinical research study content standards in collaboration with sixteen partner organizations including NCI.
  • Analysis Data Model (ADaM) supports efficient generation, replication, review and submission of analysis results from clinical trial data.
  • Standard for Exchange of Non-Clinical Data (SEND) extends Study Data Tabulation Model (SDTM) for non-clinical studies and now includes some 1,900 additional terms.

(For more information, visit the NCI website.)

The CDISC Shared Health and Research Electronic Library (SHARE) project is also building a collaborative authoring platform for harmonizing data elements from multiple organizations, using LexWiki for its initial prototype. CDISC has created a data element curation process, including terminology linking, using the LexWiki and LexGrid technologies; this process provides a collaborative framework and platform for representation and harmonization of clinical study data elements. CDISC will use open tools created by NCI as the basis for developing SHARE.

National Council of Prescription Drug Providers (NCPDP)

NCPDP is a not-for-profit, ANSI-accredited, Standards Development Organization with over 1,600 members representing virtually every sector of the pharmacy services industry. NCPDP creates and promotes the transfer of data related to medications, supplies, and services within the healthcare system through the development of standards and industry guidance. In 2009, NCPDP decided to partner with EVS to use NCIt subsets to support two of those standards, employed by some 200 vendors serving approximately 15,000 pharmacies nationwide:

  • NCPDP SCRIPT Standard supports messages for new prescriptions, prescription changes, refill requests, prescription fill status notification, prescription cancellation, medication history, and transactions for long term care environments. Many large providers such as First DataBank and Surescripts, the nation's largest e-prescriber, use this standard. Surescripts alone connects thousands of pharmacies across the US, and is connected to the largest network of payers and Medicaid Fee for Service payers nationwide.
  • NCPDP Telecommunication Standard supports the electronic communication of claims and other transactions between pharmacy providers, insurance carriers, third party administrators, and other responsible parties.

(For more information, visit the NCI website.)

Federal Medication Terminologies (FMT)

Work started in 2002 as an interagency collaboration between NCI EVS, FDA, VHA, and NLM – joined later by AHRQ, CMS, DoD, and EPA – to improve the exchange and public availability of medication information with coordinated development of terminology standards. The initial FMT terminology set has been endorsed by U.S. Federal standards efforts including the National Committee on Vital and Health Statistics (NCVHS), Consolidated Health Informatics (CHI), the Healthcare Information Technology Standards Panel (HITSP), and the Office of the National Coordinator for Health Information Technology (ONC) within the Department of Health and Human Services (HHS). (For more information, visit the NCI website.)

Veterans Health Administration (VHA)

VHA has worked closely with EVS since 2002. Under an ongoing Memorandum of Understanding, VHA works with EVS on collaborative terminology policy and products, including content collaboration and publication of the VA's National Drug File Reference Terminology (NDF-RT), used by both agencies as a drug information reference resource.

The VHA also performed a thorough comparison of the functional capabilities of LexEVS to those of other terminology servers. The VA provided the results to the VKC, which transformed the matrix into a document that can be used by potential adopters of LexEVS as they evaluate the capabilities of the system. This is an example of a valuable contribution from the community that is not code-based; in an open source model, contributions of documentation can be as important as contributions of code.

Health Level 7 (HL7)

EVS supports terminology content for the Regulated Clinical Research Information Management (RCRIM) committee of HL7, and for other committees as appropriate including Patient Safety, Pharmacy, Clinical Genomics, and the Clinical Interoperability Council.

World Health Organization (WHO)

WHO requested in June, 2009, a Classification Markup Language (ClaML) LexEVS data processing program that could be used to render ICD-10 in preparation for, and as the foundation of, ICD-11. This is an example of an international standards organization using NCI's open source tooling to support the development of a new version of a major international terminology standard.

WHO work on ICD-11 is also using NCI Thesaurus as an important source of cancer terminology and definitions.

Scrollbar
iconsfalse

...

EVS has supported DCB research on mouse and other animal models of cancer for more than 10 years. EVS has helped develop and maintain accurate coding and classification terminology for animal models, and has worked with NCI and community partners to develop accurate mappings between terminologies currently in use. Key NCI components of this effort are described here, while community partners are described later 14 - User Profiles - Broader Community.

Mouse Models of Human Cancer Consortium (MMHCC) was established by NCI in 1999 to accelerate the development and validation of mouse models by the scientific community. When the MMHCC was initiated, one of the early projects was to create a repository of curated information about animal models that have been employed in cancer studies, called the Cancer Models Database (now caMOD). EVS staff participated in developing the classifications of mouse diagnoses used for annotating the mouse models, and provided support for additional terminology such as strains and anatomy. All of this terminology has been incorporated into NCI Thesaurus (NCIt), used by caMOD and other users through both browser and programming interfaces. caMOD annotates information with NCIt terminology, and uses the LexEVS API directly to generate anatomy and diagnosis tree hierarchies. 400 concepts were added or updated for caMOD in the last-recorded six month period.

EVS has supported periodic updates to this animal model terminology, and has extended terminology support to cover rats and zebrafish, using existing community standards where available:

  • International Harmonization of Rat Nomenclature (RENI) was used as the foundation for the Terminology of Rat Pathologic Diagnoses in NCI Thesaurus (NCIt).
  • Zebrafish Information Network (ZFIN) zebrafish anatomy is provided as a standalone terminology in EVS systems including the NCI Term Browser.

MMHCC has merged with the Mouse Repository at Frederick National Research Laboratories, which provides mouse cancer models and associated strains, live and cryopreserved. Additional future support for updating the diagnosis terminology to reflect new models is anticipated.

For more information, visit the NCI eMICE website.

EVS Related References

  1. Bodenreider O, Hayamizu TF, Ringwald M, De Coronado S, Zhang S.
    Of mice and men: aligning mouse and human anatomies.
    AMIA Annu Symp Proc. 2005:61-5. PubMed PMID: 16779002; PubMed Central PMCID: PMC1560846. [PubMed]
  2. Hayamizu TF, de Coronado S, Fragoso G, Sioutos N, Kadin JA, Ringwald M.
    The mouse-human anatomy ontology mapping project.
    Database (Oxford). 2012 Mar 20;2012:bar066. Print 2012. PubMed PMID: 22434834. [PubMed] [Full Text]
  3. Kogan SC, Ward JM, Anver MR, Berman JJ, Brayton C, Cardiff RD, Carter JS, de Coronado S, Downing JR, Fredrickson TN, Haines DC, Harris AW, Harris NL, Hiai H, Jaffe ES, MacLennan IC, Pandolfi PP, Pattengale PK, Perkins AS, Simpson RM, Tuttle MS, Wong JF, Morse HC 3rd; Hematopathology subcommittee of the Mouse Models of Human Cancers Consortium.
    Bethesda proposals for classification of nonlymphoid hematopoietic neoplasms in mice.
    Blood. 2002 Jul 1;100(1):238-45. PubMed PMID: 12070033. [PubMed]

NCI Division of Cancer Control and Population Sciences (DCCPS)

DCCPS collaboration includes several terminology projects related to cancer classification, drugs, chemotherapy regimens, and statistics. DCCPS is currently launching a new initiative on standardized terminology for population health data collection.

Portfolio Management Application (PMA-DCCPS): EVS has worked with DCCPS for a number of years to integrate PMA-DCCPS grant coding terminology with other EVS resources. NCIt now includes more than 1,500 concepts for PMA grant coding. PMA terms are also inserted and appear in the NCI Metathesaurus as a separate terminology.

NCI Division of Cancer Prevention (DCP)

DCP has used EVS, and worked consistently with EVS, since 2002, including the following collaborations and uses:

  • Use of NCIt agent information in DCP systems.
  • Joint work on improved coverage of nutritional and other preventive agents.
  • Joint work in wider working groups and other initiatives to harmonize broader NCI agent and adverse event coding practices.

EVS Related References

  1. Kaefer CM, Milner JA.
    The role of herbs and spices in cancer prevention.
    J Nutr Biochem. 2008 Jun;19(6):347-61. Review. PubMed PMID: 18499033; PubMed Central PMCID: PMC2771684. [PubMed] [PubMed Central]

NCI DCP and DCTD

EVS staff provides terminology support for the Community Clinical Oncology Program (CCOP), including concepts for use in coding four (4) major clinical trials involving 85,000 patients. An estimated total of 500 studies use NCI Thesaurus terminology.

NCI Division of Cancer Treatment and Diagnosis (DCTD)

Cancer Therapy Evaluation Program (CTEP)

The Cancer Therapy Evaluation Program (CTEP) has had many and sustained collaborations with EVS from 1999 onwards, including:

  • Use of NCI Thesaurus (NCIt) terminology for protocol abstraction.
  • Harmonization and use of NCIt drug and molecular target information in CTEP systems.
  • Harmonization and integration of CTEP disease classification with NCIt, PDQ and MedDRA, involving several detailed comparative mappings and analyses as well as concept based mappings in the NCI Metathesaurus (NCIm).
  • Joint development, together with other partners, of the redesigned Common Terminology Criteria for Adverse Events (CTCAE) v.4, which has been widely adopted since its release in 2010 (see the detailed description below).

Common Terminology Criteria for Adverse Events (CTCAE)

CTCAE, created by CTEP in 1983, is used throughout the entire oncology community as the standard classification and severity grading scale for adverse events in cancer therapy clinical trials and other oncology settings. It is also used in a number of non-oncology trials and settings.

Version 4, released in May 2009, is a major update based on extensive international participation by stakeholders and experts. It is harmonized with MedDRA at the Adverse Event (AE) level, includes revised AE terms and severity indicators to reflect clinical effects identified with current oncology interventions, and was selected as a caBIG® vocabulary standard. This version is used by more than 50 academic and research organizations, as well as many commercial and non-profit organizations. Five different Apple applications utilize the NCI Thesaurus version of the CTCAE data, and cite NCIt as the source.

CTCAE is designed to integrate into information networks for safety data exchange, and plays a major role in data management for AE data collection, analysis, and patient outcomes associated with cancer research and care. EVS played a central role in designing and managing this effort, working closely with CTEP, DCP, caBIG®, the FDA, and many participants from the broader community. The revision was developed and deployed using various EVS tools including the BiomedGT Wiki, Protégé editing tools, LexEVS terminology server, NCI Term Browser, and the EVS ftp site .

Cancer Diagnosis Program (CDP) - Diagnostics Evaluation Branch

  • EVS is supporting gene nomenclature used in a new CDP Biomarker project, including updating Human Genome Organisation (HUGO) Gene Nomenclature Committee (HGNC) terminology in the EVS servers so it is accessible to CDP curators. See HGNC on NCI Term Browser.
  • In an extension to this project, EVS will be creating gene and protein sequence variations in the NCIt, according to HGVS guidelines, for genes/proteins of therapeutic interest as requested by CDP. The initial request is 150 genes (in progress), with about 180 protein variants, 300 gene variants, 300 fusion genes, and 300 fusion proteins.
  • This work is to support creation of an application to retrieve content from the NIH Clinical Trial Database into the NCI Clinical Trials Reporting Program (CTRP), and is being done jointly with DCTD, NCI/OCPL, NCI/CCR and NIH/NLM.

EVS Related References

  1. Chen AP, Setser A, Anadkat MJ, Cotliar J, Olsen EA, Garden BC, Lacouture ME.
    Grading dermatologic adverse events of cancer treatments: the Common Terminology Criteria for Adverse Events Version 4.0.
    J Am Acad Dermatol. 2012 Nov;67(5):1025-39. doi: 10.1016/j.jaad.2012.02.010. Epub 2012 Apr 11. PubMed PMID: 22502948. [PubMed]
  2. Cimino JJ, Hayamizu TF, Bodenreider O, Davis B, Stafford GA, Ringwald M.
    The caBIG terminology review process.
    J Biomed Inform. 2009 Jun;42(3):571-80. Epub 2008 Dec 25. PubMed PMID: 19154797; PubMed Central PMCID: PMC2729758. [PubMed]

NCI Division of Extramural Activities (DEA)

DEA is supported by EVS, which helps collect, develop and map grant-related terminology, including representing NCI in the NIH Research, Condition and Disease Categorization (RCDC) effort.

NCI Office of Communications and Public Liaison (OCPL)

OCPL co-managed EVS with CBIIT until late 2007, and has continued as an important partner since that time. Some key areas of ongoing collaboration are:

  • PDQ Terminology has been used for decades to code cancer clinical trials and other NCI scientific and public information resources, including NCI's Clinical Trials Reporting Program (CTRP) initiative. EVS has used PDQ terminology as a core component of its NCI Thesaurus (NCIt) reference terminology, and has worked to harmonize with and add to PDQ terminology even as NCIt was extended in many ways not required for PDQ itself. EVS took over and carries on efforts to harmonize and cross-link both PDQ terminology and NCIt with other NCI coding terminologies including CTEP disease and adverse event terminologies, NCI Developmental Therapeutics Program drug terms, and terminology from DCCPS and DCP. EVS continues to work with OCPL on strengthening PDQ terminology as a coding and information retrieval resource. See PDQ on NCI Term Browser and the PDQ to NCIt Mapping.
  • NCI Drug Dictionary provides technical definitions, alternate names, and links to related information for more than 3,000 agents that are being used in the treatment of patients with cancer or cancer-related conditions. Each entry includes a link to a more detailed entry in NCIt, which provides the information presented, as well as links to lists of open and closed cancer clinical trials on NCI's Web site, Cancer.gov. Each month, the NCI Drug Dictionary is used by over 30,000 unique visitors who view more than 65,000 pages.
  • Cancer.gov Database of Cancer Clinical Trials is updated daily and covers over 11,000 clinical trials now accepting participants, plus more than 25,000 others that are no longer recruiting. NCIt drug terminology is used to index PDQ trials, and EVS has contributed to the development of PDQ Terminology used to code cancers and related conditions, procedures, and chemotherapy regimens.
  • NCI Dictionary of Cancer Terms defines more than 7,000 cancer and biomedical terms in non-technical language. Terms and definitions are reviewed by a multidisciplinary panel of reviewers, and approximately 50 new and 50 revised terms are included each month. The dictionary is available as a stand-alone resource on every Cancer.gov Web page, and is widely used by other institutions and Web sites. Its contents are integrated into both NCI Thesaurus and NCI Metathesaurus, providing an important resource especially for non-technical users.

EVS Related References

  1. De Coronado S, Haber MW, Sioutos N, Tuttle MS, Wright LW.
    NCI Thesaurus: Using Science-Based Terminology to Integrate Cancer Research Results.
    Proceedings of the 11th World Congress on Medical Informatics (Medinfo 2004) Amsterdam: IOS Press 2004, pp. 33-37. Also cited as: Stud Health Technol Inform. 2004;107(Pt 1):33-7. [PubMed]
  2. Hubbard SL.
    Information systems in oncology.
    Cancer: Principles & Practice of Oncology, 6th ed. Devita VT, Hellman S, Rosenberg SA, eds. Philadelphia: Lippincott Williams & Wilkins; 2001. pp. 3135–46.
  3. Hubbard SM, Setser A.
    The Cancer Informatics Infrastructure: a new initiative of the National Cancer Institute.
    Semin Oncol Nurs. 2001 Feb;17(1):55-61. Review. PubMed PMID: 11236366. [PubMed] [Full Text]
  4. Sioutos N, De Coronado S, Haber MW, Hartel FW, Shaiu WL, Wright LW.
    NCI Thesaurus: A Semantic Model Integrating Cancer-Related Clinical and Molecular Information.
    Journal of Biomedical Informatics 2007 Feb;40(1):30-43. Epub 2006 Mar 15. [PubMed]

Other NCI User Profiles

Cooperative Human Tissue Bank (CHTB):  EVS has supported terminology creation and editing for this network of research institutions, established by the NCI Cancer Diagnosis Program in 1987 and now including six divisions located at Vanderbilt, U. Penn, UAB School of Medicine, Nationwide Children's Hospital, Ohio State, University of Virginia. CHTB hosts NCI funded tissue facilities and services providing remnant human tissue and fluids from routine procedures to investigators. There is active use by 14 academic and research organizations and eight (8) commercial organizations. EVS staff assisted with matching up terminology used by these groups to NCIt terminology, creating new NCIt concepts and definitions as needed.

Cancer Central Clinical Database (C3D): EVS provides support for C3D, largely through providing the new and updated terminology and definitions for case report forms. C3D currently supports electronic submission of clinical trials data to the NCI Clinical Data System (CDS) and the Clinical Trials Monitoring Service (CTMS/Theradex).

OPEN (Oncology Patient Enrollment Network): This web-based registration system for patient enrollments onto NCI-sponsored Cooperative Group clinical trials is a highly active project; most terminology supplied for this is standard demographic terminology.