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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. 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:

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Marker Assay Use - Include v4.4
Marker Assay Use - Include v4.4

Biomarker Purpose
(CDE ID 2939397)

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

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Marker Purpose - Include v4.4
Marker Purpose - Include v4.4

NCI ID

The

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Trial Attribute NCI ID - Include v4.4
Trial Attribute NCI ID - Include v4.4

NCT ID

The

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Trial Attribute NCT ID - Include v4.4
Trial Attribute NCT ID - Include v4.4

Lead Org ID

The

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Trial Attribute Lead Org Trial ID - Include v4.4
Trial Attribute Lead Org Trial ID - Include v4.4

Phase

The

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Trial Attribute Phase - Include v4.4
Trial Attribute Phase - Include v4.4
For detailsinformation, 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 a list of values 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

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Trial Attribute Official Title - Include v4.4
Trial Attribute Official Title - Include v4.4
For information, refer to Abstracting Trial Descriptions, Titles, and Identifiers.

Current Trial Overall Status

The

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Trial Attribute Current Trial Status - Include v4.4
Trial Attribute Current Trial Status - Include v4.4
For details, refer to Trial Status Values in the CTRP and ClinicalTrials.gov and Abstracting Trial Statuses.

Processing Status

The

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Trial Attribute Current Trial Processing Status - Include v4.4
Trial Attribute Current Trial Processing Status - Include v4.4
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.