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:

Biomarker Purpose
(CDE ID 2939397)

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

NCI ID

The

NCT ID

The

Lead Org ID

The

Phase

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

Current Trial Overall Status

Processing Status

The 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.