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 | Value that describes the biomarker use. Valid values include:
|
Biomarker Purpose | Value that describes the reason or intention of the biomarker in the clinical study. Valid values include:
|
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 |
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 |