Therascreen® KRAS RGQ PCR Kit

Study Overview
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Brief Summary
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An interventional, prospective IVD device study for the testing of DNA extracted from tumor tissue biopsy samples from patients with Colorectal Cancer (CRC) who have previously tested positive for the KRAS G12C mutation for potential inclusion into the Amgen Phase III clinical trial (Protocol No 20190172) to demonstrate clinical performance of the therascreen® KRAS RGQ PCR Kit

Detailed Description
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This is an interventional, prospective clinical performance study protocol for the testing of DNA extracted from tumor tissue biopsy samples obtained from patients with CRC using the KRAS kit. (RES, CNB are acceptable however (Fine needle aspiration (FNA), brushings, cell pellets from pleural effusion, bone biopsy and lavage samples are not acceptable. Up to 200 patient tissue samples (from approximately 100 clinical trial sites), obtained in the Clinical Study (Protocol No. 20190172), will be tested using the KRAS Kit. The testing will be performed at the l device clinical testing sites, Q2 Solutions Laboratories in the two geographical locations: USA and UK. The clinical study protocol (Protocol No. 20190172) requires an estimated total of 153 evaluable patient tissue biopsy samples to be tested. Approximately 200 patient biopsy samples are expected to be supplied to the test sites to reach this target. The KRAS G12C mutation status of patients enrolling on the clinical trial is expected to be known prior to patient screening hence the relatively low estimate of screen failures. If existing local data are used for patient selection, the archival tumor sample is requested to be sent to the Test Site for confirmation of KRAS G12C status prior to enrollment. For the US (Site 001) and EU (Site 002) Test Sites a FFPE tissue block (preferred) and a copy of the de-identified pathology report is requested by the Test Site or a minimum of 9 - 20 unstained slides (4-5 µm) should be submitted during screening for prospective central confirmation. If no remaining tumor tissue is available from the biopsy used for determining KRAS G12C status then an alternative archival tumor sample may be submitted to the Test Site. If this is unavailable or if there is insufficient quality of tumor sample, a new biopsy will need to be provided for central KRAS G12C confirmation. The primary objective of the Amgen Clinical Study is to evaluate the progression free survival assessed by MODIFIED RECIST 1.1 criteria of Sotorasib (AMG 510) at 2 different dose levels as a combination therapy with panitumumab, compared to patients treated with investigators choice comparator (trifluridine and tipiracil or regorafenib) in patients using the Clinical Study Assay, therascreen®KRAS Kit to assess the presence of the KRAS G12C mutation in CRC, a key eligibility criteria. The clinical data from the study will be used to determine the drug-device efficacy to support future regulatory submissions for the device-drug combination.

Official Title
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An Interventional, Prospective IVD Device Study for the Testing of DNA Extracted From Tumor Tissue Biopsy Samples From Patients With Colorectal Cancer (CRC) Who Have Previously Tested Positive for KRAS G12C Mutation Into the Amgen Phase III Clinical Trial (Protocol No 20190172) to Demonstrate Clinical Performance of the Therascreen® KRAS RGQ PCR Kit.

Conditions
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Colo-rectal Cancer

Intervention / Treatment
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* Diagnostic Test: therascreen® KRAS RGQ PCR Kit


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients identified for inclusion in Phase 3 of the Clinical Study (Protocol No. 20190172) , will provide an archived tumor tissue (FFPE) i.e. prior to enrolment the investigator should have determined that there is sufficient archived tumor tissue (collected within 5 years of enrolment). If archived tumor tissue is not available, then fresh tumor tissue sample must be obtained. Acceptable biopsies for deep 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. tumor biopsy sample must be obtained within the 28 day screening period of Phase 3 of the Amgen Clinical Study (Protocol No. 20190172). This sample will be sent to Q2for testing of KRAS G12C mutation.Tumor tissue for KRAS G12C mutation testing may be submitted to the testing laboratory (Q2) either as FFPE blocks or unstained slides, along with the corresponding pathology report. Patients will only be selected if they have signed the ICF permitting the use of their sample in the development of diagnostics. Evaluation of the patient's eligibility is the responsibility of Amgen, the sponsor of the Clinical Study (Protocol No. 20190172). Exclusion Criteria: Patients whose tumor tissue biopsy samples are not Clinical Trial Assay evaluable will be excluded from the study if no other tissue is available for testing. Additionally, patients with samples identified for the study which have insufficient testing material will also be excluded, as will specimens which have undergone decalcification if no other tissue is available.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Clinical Performance Study Protocol for therascreen® KRAS RGQ PCR Kit<br>The therascreen® KRAS RGQ PCR Kit is a real-time qualitative PCR assay used on the Rotor-Gene Q MDx (US) instrument for the detection of seven somatic mutations in the human KRAS oncogene, using DNA extracted from formalin-fixed, paraffin-embedded (FFPE), colorectal cancer (CRC) tissue | Diagnostic Test: therascreen® KRAS RGQ PCR Kit<br>* Utilize a Clinical Trial Assay, the KRAS Kit, as a screening test in Phase 3 of Clinical Study (Protocol No. 20190172) in order to identify patients with CRC with KRAS G12C mutation positive tumors This will allow the clinical data from the study to be used to determine the drug-device efficacy to support future regulatory submissions for the device-drug combination.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| therascreen® KRAS RGQ PCR Kit | Device study is to utilize a Clinical Trial Assay, the KRAS Kit, as a screening test in Phase 3 of Clinical Study (Protocol No. 20190172) in order to identify patients with CRC with KRAS G12C mutation positive tumors | 5 business days |