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, which detects KRAS gene changes in tumor tissue samples. It enrolled patients who had provided consent for the relevant protocol (Amgen Protocol No. 20170543). This is a study without a phase and has been completed.

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

Completed

Sponsor

QIAGEN Gaithersburg, Inc

Intervention

therascreen® KRAS RGQ PCR Kit

Start date

7/1/2019

Estimated completion

11/23/2020

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:

* All patients who provided consent (by signing and dating the Consent Form for Amgen Protocol No. 20170543), may be included in the device study.

Exclusion Criteria:

* Patients whose tumor tissue biopsy samples are not Clinical Trial Assay evaluable will be excluded from the study. Additionally, patients with samples identified for the study which have insufficient testing material will also be excluded, as will specimens which have undergone decalcification.