Clinical Study Testing DNA Extracted From Tumour Tissue Biopsy Samples, Using the Therascreen® KRAS RGQ PCR Kit

Plain-language summary

This study tests the performance of the Therascreen® KRAS RGQ PCR Kit, which detects KRAS gene changes in DNA obtained from tumor tissue biopsy samples. It enrolled patients who had provided consent for the relevant protocol. 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

3/13/2020

Estimated completion

4/22/2021

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 ICF for Protocol No. 20190009), may be included in the Clinical Performance Study.

Exclusion Criteria:

* Patients whose tumour tissue biopsy samples are not Clinical Study Assay evaluable will be asked to provide further tumour tissue biopsy samples. Patients with samples identified for the study which have insufficient testing material will have their sample excluded, as will specimens which have undergone decalcification.