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