NIH | National Cancer Institute | NCI Wiki  

The following table describes the data elements displayed in the Biomarkers report and their correlates in the NCI CTRP Protocol Abstraction (PA) application. For instructions on revising the biomarker information in a CTRP trial record, refer to Abstracting Biomarkers.

Data Element

Description and Corresponding CTRP PA Data Element Where Applicable


Biomarker Name

The name of the biomarker as indicated in the Protocol document.

Biomarker Use
(CDE ID 2939411)

A value that describes the biomarker use. Valid values include:

  • Integral. Tests that must be performed for the trial to proceed. Includes biomarkers evaluated for the purpose of eligibility/enrollment, stratification, and treatment assignment.
  • Integrated. Tests that are hypothesis-driven or measured to support objectives.

Biomarker Purpose
(CDE ID 2939397)

A value that describes the reason or intention of the biomarker in the clinical study. Valid values include:

  • Eligibility Criterion. Biomarker measured to help determine if patients can participate in the research trial.
  • Treatment Assignment. Biomarker measured to help determine what treatment will be administered (or how much is given).
  • Stratification Factor. Biomarker measured to help classify patients into strata as part of the randomization process or for purposes of data analysis.
  • Research. Biomarker measured to support a hypothesis or trial objective which cannot be considered response assessment.
  • Response Assessment. Biomarker measured to help determine how well the treatment is working or to characterize the impact of treatment.

NCI ID

The unique ID assigned to the trial by the CTRP.

NCT ID

The unique ID assigned to the trial by the National Clinical Trial program (ClinicalTrials.gov) for trials that have been submitted to ClinicalTrials.gov Protocol Registration System (PRS) previously. This ClinicalTrials.gov ID appears as "NCT" followed by 8 numeric characters (such as NCT12345678).

Lead Org ID

The unique ID assigned to the trial by the sponsoring organization, usually an accession number or a variation of a grant number. Multiple studies conducted under the same grant must each have a unique number.

Phase

The phase of investigation, as defined by the US FDA for trials involving investigational new drugs. For information, refer to Trial Phase Value Definitions, Abstracting Interventional Trial Design, or Abstracting Non-Interventional Trial Design.

Disease Site

The anatomic site terms that identify the anatomic cancer site(s) on which a trial or study is focused. For information, refer to Data Table 4 Anatomic Site Values or Abstracting Data Table 4 Anatomic Sites. When a trial has multiple disease sites, the report uses a semicolon (;) to separate values.

Official Title

The official name of the protocol provided by the study principal investigator or sponsor (as it appears in the protocol document). For information, refer to Abstracting Trial Descriptions, Titles, and Identifiers.

Current Trial Overall Status

The current stage or state of a clinical trial or study relative to its ability to enroll participants/patients. For details, refer to Trial Status Values in the CTRP and ClinicalTrials.gov and Abstracting Trial Statuses.

Processing Status

The current status of the trial in the CTRP trial processing work flow. For information, refer to Trial Processing Statuses and Abstracting Trial Statuses.

Intervention Name

The standard name used to refer to an intervention. For drugs, this is the generic name. For investigational new drugs that do not yet have a generic name, this may be the chemical name, company code, or serial number. For information, refer to Abstracting Interventions. When a trial has multiple intervention names, the report uses a semicolon (;) to separate values.

Intervention Type

The mode of intervention, for example, drug or device. For information, refer to Abstracting Interventions. When a trial has multiple intervention types, the report uses a semicolon (;) to separate values.