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:
|
NCI ID | unique ID assigned to the trial by the CTRP. |
ClinicalTrials.gov ID | unique ID assigned to the trial by the National Clinical Trial program (ClinicalTrials.gov) for trials that have been submitted to ClinicalTrials.gov Protocol Registration System (PRS) previously. This ClinicalTrials.gov ID appears as "NCT" followed by 8 numeric characters (such as NCT12345678). |
Lead Org ID | unique ID assigned to the trial by the sponsoring organization, usually an accession number or a variation of a grant number. Multiple studies conducted under the same grant must each have a unique number. |
Phase | phase of investigation, as defined by the US FDA for trials involving investigational new drugs. |
Disease Site | 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. |
Official Title | official name of the protocol provided by the study principal investigator or sponsor (as it appears in the protocol document). |
Current Overall Status | current stage or state of a clinical trial or study relative to its ability to enroll participants/patients. |
Processing Status | current status of the trial in the CTRP trial processing work flow. |
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. |