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.

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 16

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
formalin (NBF) and embedded in paraffin.
A Formalin-Fixed Paraffin-Embedded (FFPE) tissue block (preferred), or a
minimum of 4 unstained slides (5µm sections), and a copy of the de-identified
pathology report is requested for screening. FFPE sections must be mounted on a
positively charged glass slide and tested within 111 weeks of sectioning
Acceptable biopsies for tumor tissue include core needle biopsy (CNB) or
surgical resection (RES). Fine needle aspiration (FNA), brushings, cell pellets
from pleural effusion, bone biopsy and lavage samples are not
acceptable.Additional details on the sample requirements are described in
section 7 and in the therascreen KRAS RGQ PCR Kit instructions for use
(DHF-20-1839-2-DOU-002).

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
formalin (NBF) and embedded in paraffin.
A Formalin-Fixed Paraffin-Embedded (FFPE) tissue block (preferred), or a
minimum of 4 unstained slides (5µm sections), and a copy of the de-identified
pathology report is requested for screening. FFPE sections must be mounted on a
positively charged glass slide and tested within 111 weeks of sectioning
Acceptable biopsies for tumor tissue include core needle biopsy (CNB) or
surgical resection (RES). Fine needle aspiration (FNA), brushings, cell pellets
from pleural effusion, bone biopsy and lavage samples are not
acceptable.Additional details on the sample requirements are described in
section 7 and in the therascreen KRAS RGQ PCR Kit instructions for use
(DHF-20-1839-2-DOU-002).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Objective:<br /><br>To utilize the therascreen KRAS RGQ PCR Kit, as a screening test in Amgen*s<br /><br>Phase 3 Clinical Study Protocol 20210081, in order to identify patients with<br /><br>mCRC KRAS G12C mutation positive tumors to be enrolled in the drug clinical<br /><br>trial. Results of the Phase 3 Amgen Study 20210081 will serve as the basis for<br /><br>establishing the clinical performance of the therascreen KRAS RGQ PCR Kit as a<br /><br>companion diagnostic (CDx) for the identification of patients with metastatic<br /><br>colorectal cancer, who may benefit from treatment with sotorasib.<br /><br><br /><br>Endpoint:<br /><br>To demonstrate that the therascreen KRAS RGQ PCR Kit is safe and effective to<br /><br>identify patients for sotorasib treatment, as supported by the efficacy and<br /><br>safety endpoints from the sotorasib clinical trial.</p><br>

Secondary Outcome Measures