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The following table describes the data elements displayed in the Biomarker Reports and their correlates in the NCI CTRP Protocol Abstraction (PA) application.

Data Element

Description and Corresponding CTRP PA Data Element Where Applicable


Biomarker Name

Name of the biomarker as indicated in the Protocol document

Biomarker Use
(CDE ID 2939411)

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)

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

Number assigned to the trial by the National Cancer Institute

ClinicalTrials.gov ID

Number assigned to the trial by ClinicalTrials.gov

Lead Org ID

Unique identification assigned to the protocol by the sponsoring organization

Phase

Phase of investigation

Disease Site

Anatomic site terms that identify the anatomic cancer site(s) on which a trial or study is focused. For a list of values, refer to Anatomic Sites.

Official Title

Official name of the protocol provided by the study principal investigator or sponsor

Current Overall Status

Overall accrual activity for the protocol

Processing Status

Status of a trial during the course of the trial processing workflow

Intervention Name

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.

Intervention Type

Mode of intervention, for example, drug or device

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