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 | A value that describes the biomarker use. Valid values include:
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Biomarker Purpose | A value that describes the reason or intention of the biomarker in the clinical study. Valid values include:
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NCI ID | The unique ID assigned to the trial by the CTRP. |
NCT ID | The 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 | The 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 | The phase of investigation, as defined by the US FDA for trials involving investigational new drugs. For information, 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 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 official name of the protocol provided by the study principal investigator or sponsor (as it appears in the protocol document). For information, refer to Abstracting Trial Descriptions, Titles, and Identifiers. |
Current Trial Overall Status | The current stage or state of a clinical trial or study relative to its ability to enroll participants/patients. For details, refer to Trial Status Values in the CTRP and ClinicalTrials.gov and Abstracting Trial Statuses. |
Processing Status | The current status of the trial in the CTRP trial processing work flow. 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. |