RECIST:  Round 5


RECISTv1.1 Module Definition

The Response Evaluation Criteria in Solid Tumors (RECIST) CRF module is used to document the questions collected when assessing the change in tumor burden as part of the clinical evaluation of cancer therapies using the RECIST guidelines.  This working group utilized a proposed set of questions and data elements that were the result of a joint National Cancer Institute – Clinical Data Interchange Standards Consortium (NCI-CDISC) standardization effort that completed just prior to the initiation of the Round 5 working group activities.

This module is constrained to content in the RECISTv1.1 guidelines, and is not inclusive of the earlier RECISTv1.0 guideline or extensions of the standard in guidelines by other organizations such as the World Health Organization (WHO) and the CDISC.  There is one exception, the inclusion of a single CDISC question which is conditional when an organization may be reporting their RECIST data based on the CDISC Study Data Tabulation Module (SDTM) format.


The RECISTv1.1 CRF module variables, or questions, have been divided into 4 groupings as viewed by researchers and statisticians:

 

 

  1. Imaging Event – describes administrative data collected as part of an imaging procedure used to examine a tumor based on the RECISTv1.1 guidelines.  At a minimum the method of assessment and date of the imaging are required, with additional questions like study timepoint and lesion measurement date being optional.  To support reporting to the FDA via the Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) system, the tumor identification method is provided for that use case only. 
  2.  Lesion - describes characteristics of the lesion such as whether it is measurable or non-measurable, the type of lesion, and its size as physically measured.  The lesion is also identified as a target or non-target.  For post baseline timepoints, new lesion may be identified.  All lesions are defined by their location and assigned a unique identifier to be used in follow up imaging studies.  The presences or absence of lymph nodes may also be tracked depending on the study requirements.    NOTE: The lesion measurement question is unique in that it was partitioned differently based on its use.   A measurement is conditional if a protocol includes the possibility of collecting target lesion data; optional for non-target lesions.   
  3.  Imaging Cycle - describes the observations following the initial or baseline assessment.  The questions collect information on target and non-target lesion with regard to their response to treatment using the response criteria defined in the RECISTv1.1 guideline. The questions collect information on the overall tumor burden and response, as well as lesion response, at a specific timepoint.  In a number of the CRFs reviewed, an optional comment field was included to capture textual information beyond the specific response values for each target and non-target lesion.
  4.  Computed - describes summary variables which are computed based on information and assessment of timepoint results. There was some discussion as to whether these needed to be included as in some instances the values were calculated based on the data collected and not recorded on a CRF.  Since these values were included in a results table as part of the RECISTv1.1 guideline, it was decided to include them in the module for completeness.    


Downloads

RECIST v1.1 NCI CRF Standards created on October 30, 2018

iRECIST NCI Standards created on October 30, 2018

irRECIST NCI Standards created on October 30, 2018

irRC NCI Standards created on October 30, 2018

RECIST NCI CRF Standards created on June 11th, 2018

RECISTv1.1 NCI CRF Standards created on December 9th, 2013

Status

 Pilot workflow steps. 1) CTROC reviews and approves. 2) Biostatistician reviews and approves for Cooperative Groups. 3) A participant for each of the NCI cooperative groups approves any content that has changed since. 4) Working group reviews and responds to changes from community review and CBIIT staff review content to ensure the use of standards. 5) Module is distributed for community review. 6) Working group, with CBIIT curator matches data elements to all questions and achives consensus on final list of elements. 7) Working group reviews and partitions content as Mandatory, Conditional, Optional, or non-harmonized. 8) Working group, NCI Cooperative Groups and NCI divisions aggregate and identify common content to retain, resolves discrepancies, and achieves harmonization. 9) CBIIT staff collects existing CRFs, and creates and inventory of content.

Metrics

CRF Stars:  Working Group Membership

* Represents working group leads

No.

First Name

Last Name

Affiliation

1BrianCampbellCTEP
2JoeChen
3JaniceChilliSAIC
4MaryCooperSAIC
5JeanCormackACRIN
6NeeshaDesaiEssex Management
7KristenEngelGOG Statistical and Data Center
8DenaFlaminiACRIN
9KerryHigginsECOG
10DavidHillmanMayo
11EleanorLeung-HollinsCALGB/Alliance Statistics and Data Center (Duke)
12PatMongkolwatNorthwestern University
13ElizabethNessCCR
14SusanPanonniCity of Hope
15RebeccaPaulusRTOG
16DianneReevesNIH
17FrankSpinaEssex Management
18TinaTaylorACRIN
19MaryVienneauECOG
20ChristinaWarmingtonEssex Management