Herschel - CPSP ID: SMF-20-1839-001
Research type
Research Study
Full title
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.
IRAS ID
309738
Contact name
Ayaskant Pany
Contact email
Sponsor organisation
Qiagen Manchester Ltd
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
EudraCT number (Amgen’s Clinical Study 20190172) , 2021-004008-16
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
This study is being conducted to demonstrate clinical performance of the therascreen® KRAS RGQ PCR Kit (already available on the market), for a new investigational use: to identify patients with CRC KRAS G12C mutation positive tumors by testing DNA extracted from tumor tissue biopsy samples from patients with Colorectal Cancer (CRC), who have previously tested positive for the KRAS G12C mutation.
The study is sponsored by QIAGEN Manchester Ltd and the primary objective is to utilize the clinical study assay as a screening test in Phase 3 of Amgen’s Clinical Study Protocol 20190172.
It is estimated that approximately 200 patient tissue biopsy samples from 12 countries will be obtained as part of enrolment into the Amgen's 20190172 trial. The expected enrolment period is approximately 12 months, which is therefore also the expected duration of this clinical performance study.The testing with the therascreen® KRAS RGQ PCR Kit of the samples originating from France, Germany, Greece, Italy, Spain and UK will take place at Q² Solutions – West Lothian, Scotland.
The KRAS G12C mutation is estimated to occur in approximately 13% of lung adenocarcinoma (including Non-Small Cell Lung Cancer (NSCLC)), 3% of Colorectal Cancer (CRC), and 1% to 2% of numerous other solid tumors (including pancreatic, endometrial, bladder, ovarian, and small cell lung tumors). This specific mutation has been identified as a putative oncogenic driver in several types of solid tumors including NSCLC.
Lay Summary of Results
Final results will be reported after global end of study (12Mar2025)
Has the registry been updated to include summary results?: No
If yes - please enter the URL to summary results:
If no – why not?: Results are not available as study is ongoing
Did you follow your dissemination plan submitted in the IRAS application form (Q A51)?: Pending
If yes, describe or provide URLs to disseminated materials:
If pending, date when dissemination is expected: 12/03/2025
If no, explain why you didn't follow it:
Have participants been informed of the results of the study?: Pending
If yes, describe and/or provide URLs to materials shared and how they were shared:
If pending, date when feedback is expected: 12/03/2025
If no, explain why they haven't:
Have you enabled sharing of study data with others?: No
If yes, describe or provide URLs to how it has been shared:
If no, explain why sharing hasn't been enabled: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Have you enabled sharing of tissue samples and associated data with others?: No
If yes, describe or provide a URL:
If no, explain why: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.REC name
London - Stanmore Research Ethics Committee
REC reference
22/LO/0065
Date of REC Opinion
1 Mar 2022
REC opinion
Further Information Favourable Opinion