DHF-20-1839-2: Clinical Performance Study Protocol for Therascreen® KRAS RGQ PCR Kit

Plain-language summary

This study evaluates the clinical performance of the therascreen® KRAS RGQ PCR Kit, a diagnostic test, in detecting the KRAS G12C mutation in tumor tissue. People who consent to have their tumor tissue tested with this kit can take part. It is a study without an assigned phase and is still enrolling participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Not Applicable

Status

Recruiting

Sponsor

QIAGEN Gaithersburg, Inc

Intervention

therascreen® KRAS RGQ PCR Kit

Start date

12/22/2023

Estimated completion

10/31/2030

Countries

United Kingdom

Related genes

Locations

• Manchester, United Kingdom

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* Subjects who consent to participate in the eligibility screen for Protocol 20210081 will have their tumor tissue tested for the presence of KRAS G12C mutation under the proposed performance study.

Exclusion Criteria:

* There is no separate inclusion and exclusion criteria for the performance study.