Create Clinical Trials
Users can create clinical trial records when they need to add a clinical trial or edit information about a clinical trial present in an external knowledge base.
Two ways to create clinical trials: from scratch or by editing external knowledge base assertions.
Creating Clinical Trials
From scratch:
Navigate to the Biomarker Details page.
Select Create New Assertion in the top-right corner or under the list of variant assertions to be included in the report.
In the Clinical Trial tab, add information to the fields described below.
From an external knowledge base:
Navigate to the Biomarker Details page.
Select a clinical trial from an external knowledge base (e.g., CKB).
Select Copy to new assertion in the menu next to "Report".
Add and edit information in the fields described below.
Clinical Trial Fields
Level
For more information, refer to Interpret a Variant.
Consequences
For more information, refer to Interpret a Variant.
Status
The Status field describes the status of TMB, MSI, and GIS that the assertion is applicable to.
The following categories are available:
TMB-High
TMB-Low
MSI-High
MS-Stable
GIS-High
GIS-Low
HRD
The HRD field indicates if the assertion is related to HRD for GIS and BRCA1 and BRCA2 variants.
The following categories are available:
Undetermined
Positive
Negative
Title
The Title field indicates the clinical trial title.
Registry
The Registry field indicates the clinical trial registry (e.g., https://clinicaltrials.gov/).
Registry ID
The Registry ID field indicates the clinical trial registry identifier (e.g., NCT1234).
Phase
The Phase field indicates the phase of the clinical trial (e.g., Phase III).
External Link
The External Link indicates the URL for the clinical trial record online.
Disease
For more information, refer to Interpret a Variant.
Location
The Location field indicates the city, state, and country of the clinical trial.
Multiple locations can be added.
Country is required.
Approval Status
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