Metastatic Colorectal Cancer (mCRC)NCT06645236
DHF-20-1839-2: Clinical Performance Study Protocol for Therascreen® KRAS RGQ PCR Kit
A study testing therascreen® KRAS RGQ PCR Kit in people with Metastatic Colorectal Cancer (mCRC), run by QIAGEN Gaithersburg, Inc at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer (mCRC)
- What is being tested?
- therascreen® KRAS RGQ PCR Kit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Dec 2023to 31 Oct 2030
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- There is no separate inclusion and exclusion criteria for the performance study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Parul Choudhary contact
United Kingdom1 site, 1 recruiting
- Recruiting
QIAGEN Gaithersburg, Inc
Manchester, Manchester, M130BH
Sarah G Johnson, Sarah.Johnson@qiagen.com
Parul Choudhary, Parul.Choudhary@qiagen.com
About this study
Official title: 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
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.
Read the detailed description
The proposed device clinical performance study and the medicinal clinical trial will be conducted simultaneously as a combined trial according to MDCG 2022-10. The clinical trial 20210081 is a Randomized, Open-label, Active-controlled Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb for Treatment-naïve Subjects with Metastatic Colorectal Cancer with KRAS p.G12C Mutation (CodeBreaK 301). It is estimated that approximately 450 patients from 31 countries will be enroled based on the presence of tumor KRAS G12C mutation, detected using therascreen KRAS RGQ PCR Kit, along with other clinical trial inclusion criteria, into the Phase III clinical trial. Results from the Phase 3 Amgen Study 20210081 will be used to evaluate the clinical performance of therascreen® KRAS RGQ PCR Kit as a CDx device for identification of patients with mCRC who may benefit from treatment with sotorasib in treatment-naïve patients with metastatic colorectal cancer.
- Conditions
- Metastatic Colorectal Cancer (mCRC)
- Being tested
- therascreen® KRAS RGQ PCR Kit
- Keywords
- Metastatic Colorectal Cancer, therascreen, KRAS G12C, sotorasib, Clinical Performance Study, Companion Diagnostic
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
therascreen® KRAS RGQ PCR KitDevice
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)
| Study group | Role | What they receive |
|---|---|---|
| Clinical Performance Study Protocol for therascreen® KRAS RGQ PCR Kit | Other | The 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 Receives: Device: therascreen® KRAS RGQ PCR Kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 6 years; due to end 2030
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start22 Dec 2023
- Primary completion31 Oct 2030 (estimated)
- Study completion31 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal Cancer (mCRC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- QIAGEN Gaithersburg, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sarah Johnson, Dr., Study director, Qiagen Manchester Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06645236
- Sponsor's protocol ID
- DHF-20-1839-2
- Status last verified
- Aug 2025
- First submitted
- 20 Dec 2023
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No