Clinical Trials

The Clinical Trials provides a list of all the clinical trials that have a match for the variant.

By default, the assertions are filtered by the case and ancestor diseases. Ancestor diseases are determined using SNOMEDCT, with the following exceptions:

• Descendents of neoplastic disease do not include ancestors beyond neoplastic disease.

• Non-small cell lung cancer has been added as an ancestor of adenocarcinoma of lung.

You can also filter by diseases, title, city, state, and country. Filter changes are saved and applied across variants within a case and can be reset if needed.

Classification is reported as Tier 2C (or equivalent, using your Actionability Classifications).

Clinical Trials Legend

Field Name	Description
Source	Knowledge base origin of the clinical trial.
Biomarker / Status	Indicates how the assertion is related to the variant (for example, specific amino acid change or specific exon change). Indicates the TMB, MSI, or GIS status for the clinical trial. This column is available for TMB, MSI, and GIS.
HRD	Indicates whether a clinical trial is associated with HRD positive or negative. This column is available for GIS and variants, when the selected transcript is for BRCA1/2.
Title	Title of the clinical trial.
Phase	Phase of the clinical trial.
Location	Location of the clinical trial.
Disease	Disease for the clinical trial.
Link-out Icon	Select to display the full listing about the trial in a new browser tab.
Previously Reported Icon	Any cases where the assertion was previously reported.
Actions	This column contains the following available actions: • Add to report • Archive, if the assertion is in My Knowledge Base • Copy to New Assertion, if the assertion is not in My Knowledge Base To edit an assertion, add it to the report before editing. For more information, refer to Manage Assertions.

Available Clinical Trials Knowledge Bases

Connected Insights provides the Genomenon Cancer Knowledge Base (formerly Jackson Laboratory Clinical Knowledge Base), which includes curated clinical trials from clinicaltrials.gov. For more information, refer to the Genomenon CKB website. See this page for assertion descriptions.

The following from CKB is not currently supported:

• Clinical trials with a recruitment status of completed, withdrawn, or active, not recruiting.

• Variants that have the "excluded" or "partial - excluded" requirement type.

The software does not yet determine if a case has all the requirements for a clinical trial (for example, a clinical trial requires two variants).