First CORRECT Study of MRD Detection in Colorectal Cancer
Research type
Research Study
Full title
CORRECT-MRD I: First ColoRectal cancer clinical validation study to predict REcurrence using a Circulating Tumor DNA assay to detect Minimal Residual Disease
IRAS ID
315706
Contact name
David Church
Contact email
Sponsor organisation
Exact Sciences
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 8 months, 1 days
Research summary
A lab test called, the Exact Sciences MRD test has been designed to detect biomarkers in the body that indicate a small amount of remaining or recurrent colorectal cancer (CRC) in the blood. Blood-based biomarkers have the potential to provide information about the presence or absence of very small amounts of remaining cancer. The very small amount of remaining cancer is referred to as Minimal Residual Disease (MRD) This could prove to be useful for guiding treatment decisions after surgery. It could also be a way detect cancer recurrence earlier than the currently available monitoring tests. The purpose of this research study is to review the ability of the Exact Sciences MRD test to detect cancer recurrence after surgery. The study will show if the Exact Sciences MRD test can detect the cancer prior to standard monitoring (for example, currently available blood tests or scans). This study test is not approved by any medical device regulatory authorities and is considered investigational. A current biomarker test, Oncotype Dx® Colon Cancer Recurrence Score test (Oncotype Dx®), estimates the chance of recurrence from Stage II-III colon cancer using tumor tissue. The Oncotype Dx test will be performed on initial tumor tissue. This study will assess if the Exact Sciences MRD test is better at detecting the chance of colorectal cancer recurrence than Oncotype Dx test. It will also assess if using the two tests together are better than either test alone.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
22/PR/0930
Date of REC Opinion
27 Sep 2022
REC opinion
Further Information Favourable Opinion