NL-OMON56931
Not yet recruiting
Not Applicable
An interventional, prospective IVD device study for the testing of DNA extracted from tumor tissue biopsy samples in a first line setting from patients diagnosed with metastatic Colorectal Cancer (mCRC) to determine the KRAS G12C mutation status as part of the inclusion criteria into the Amgen Phase III clinical trial (Protocol No 20210081) to demonstrate clinical performance of the therascreen® KRAS RGQ PCR Kit. - McLaren Clinical Performance Study of the therascreen® KRAS RGQ PCR Kit
QIAGEN Manchester Ltd0 sites16 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- metastatic Colorectal Cancer
- Sponsor
- QIAGEN Manchester Ltd
- Enrollment
- 16
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with pathologically documented metastatic CRC. Clinical trial 20210081
- •inclusion and exclusion criteria can be found in the clinical trial protocol
- •20210081, Section 5\.1 \& 5\.2\.
- •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.
- •Patients identified for inclusion in the Amgen Clinical Study (Protocol No.
- •20210081\), may provide an archival tumor sample collected within 5 years if
- •this is available. A fresh tumor biopsy may be taken at baseline if appropriate
- •archival tissue is not available. Tissue must be fixed in 10% neutral buffered
Exclusion Criteria
- •Patients with pathologically documented metastatic CRC. Clinical trial 20210081
- •inclusion and exclusion criteria can be found in the clinical trial protocol
- •20210081, Section 5\.1 \& 5\.2\.
- •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.
- •Patients identified for inclusion in the Amgen Clinical Study (Protocol No.
- •20210081\), may provide an archival tumor sample collected within 5 years if
- •this is available. A fresh tumor biopsy may be taken at baseline if appropriate
- •archival tissue is not available. Tissue must be fixed in 10% neutral buffered
Outcomes
Primary Outcomes
Not specified
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