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 | The name of the biomarker as indicated in the Protocol document. |
Biomarker Use | A value that describes the biomarker use. Valid values include: |
Biomarker Purpose | 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 | The |
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, refer to Anatomic Sites. When a trial has multiple disease sites, the report uses a semicolon (;) to separate values. |
Official Title | The |
Current Trial Overall Status | The For details, refer to Trial Status Values in the CTRP and ClinicalTrials.gov and Abstracting Trial Statuses. |
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. 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. When a trial has multiple intervention types, the report uses a semicolon (;) to separate values. |