The CORRECT-MRD II study will prospectively enroll patients who have undergone complete surgical resection for Stage II or III colorectal cancer (CRC) within the last 6 months.
A tissue sample from the biopsy or surgical resection will be sent to Exact Sciences for testing with the Oncotype DX Colon Recurrence Score test and the Exact Sciences’ Minimal Residual Disease Test (Exact MRD) test. In addition, blood will be drawn every 90 days for the first two years, and every 6 months for another 3 years, for up to 15 blood draws.
If a recurrence happens while participating in this study, an additional tissue sample (from the recurrence, if available from standard of care collection) will be sent for comprehensive genomic profiling along with a saliva sample.
Patients will be followed for a minimum of 3 years and up to 5 years for recurrence. This study is observational, which means that, if you choose to participate, your treatment and standard surveillance regimen will not change due to participating in this study.
However, depending on your diagnosis, you and your doctor may be provided with some test results that could assist in guiding your treatment. Please refer to the section titled “What does Participating Involve for Me?” for additional information.
Exact Sciences, NSABP Foundation, Inc. and Fight CRC are working together on an observational study called CORRECT-MRD II, enrolling Stage II and Stage III CRC patients. The purpose of this research study is to determine the ability of an investigational biomarker test, Exact MRD, to detect cancer recurrence after surgery.
Clinicaltrials.gov ID number: NCT05210283
Enrollment status: Currently enrolling
Trial sponsors: Exact Sciences