DHF-20-1839-2: Clinical Performance Study Protocol for Therascreen® KRAS RGQ PCR Kit
Interventional IVD Study Testing DNA From Tumor Tissue Biopsies From mCRC Patients to Determine KRAS G12C Mutation Status for the Inclusion in the Amgen Clinical Trial, 20210081 for the Clinical Performance of Therascreen® KRAS RGQ PCR Kit
1 other identifier
interventional
600
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 20, 2023
CompletedStudy Start
First participant enrolled
December 22, 2023
CompletedFirst Posted
Study publicly available on registry
October 16, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 31, 2030
August 15, 2025
August 1, 2025
6.9 years
December 20, 2023
August 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Detection of KRAS G12C mutation status
Detection of the KRAS G12C mutation status in DNA extracted from Formalin-Fixed Paraffin-Embedded (FFPE), CRC tissue using the therascreen KRAS RGQ PCR Kit to enrol approximately 450 KRAS G12C positive patients for clinical study protocol 20210081.
6 years; due to end 2030
Progression Free Survival (PFS)
The primary efficacy endpoint is progression free survival (PFS), defined as time from randomization until disease progression or death from any cause, whichever occur first as per the sotorasib clinical trial (Protocol 2021008).
6 years; due to end 2030
Study Arms (1)
Clinical Performance Study Protocol for therascreen® KRAS RGQ PCR Kit
OTHERThe therascreen® KRAS RGQ PCR Kit functions as part of this system, using the QIAamp DSP DNA FFPE Kit as a clinical sample concentrator, the Rotor-Gene Q MDx (RGQ) instrument as the platform on which PCR is performed, and KRAS specific software for PCR analysis and result reporting. The kit contains a Positive Control (PC) and a No Template Control (NTC) which are used to determine the validity of the test. 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
Interventions
The investigational device, therascreen® KRAS RGQ PCR Kit, will be used to determine the KRAS G12C mutation status of patients during the screening period of Amgen's clinical trial (20210081)
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
QIAGEN Gaithersburg, Inc
Manchester, Manchester, M130BH, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sarah Johnson, Dr.
Qiagen Manchester Limited
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 20, 2023
First Posted
October 16, 2024
Study Start
December 22, 2023
Primary Completion (Estimated)
October 31, 2030
Study Completion (Estimated)
October 31, 2030
Last Updated
August 15, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share