metastatic Colorectal Cancer metastatic Colorectal Cancer
Conditions
Interventions
Not Applicable, Intervention is the Clinical Trial. Please refer to the
Clinical Trial Protocol for details.
Sponsors
QIAGEN Manchester Limited
Eligibility
Age
18 Years to 99 Years
Inclusion 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 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
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective: To utilize the therascreen KRAS RGQ PCR Kit, as a screening test in Amgen*s Phase 3 Clinical Study Protocol 20210081, in order to identify patients with mCRC KRAS G12C mutation positive tumors to be enrolled in the drug clinical trial. Results of the Phase 3 Amgen Study 20210081 will serve as the basis for establishing the clinical performance of the therascreen KRAS RGQ PCR Kit as a companion diagnostic (CDx) for the identification of patients with metastatic colorectal cancer, who may benefit from treatment with sotorasib. Endpoint: To demonstrate that the therascreen KRAS RGQ PCR Kit is safe and effective to identify patients for sotorasib treatment, as supported by the efficacy and safety endpoints from the sotorasib clinical trial. | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Czech Republic, Denmark, Estonia, France, Germany, Greece, Hungary, Italy, Japan, Mexico, Netherlands, Poland, Portugal, Romania, Slovakia, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, United States
Contacts
Public ContactS Johnson
QIAGEN Manchester Limited
Outcome results
None listed