Clinical Trial

Minimal Residual Disease Testing for the Early Detection of Cancer Recurrence in Resectable Stage II-IV Colorectal Cancer Patients

Recruiting
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Summary
This clinical trial compares minimal residual disease (MRD) testing with the Haystack blood test (assay) to the Signatera® assay for the early detection of the cancer returning (cancer recurrence) in patients with stage II-IV colorectal cancer (CRC) that can be removed by surgery (resectable). MRD testing looks for evidence of remaining tumor following treatment that is only apparent using highly sensitive techniques. There are few effective tools available outside of imaging to identify CRC patients with MRD who may be at the highest risk for cancer recurrence after surgery. Early detection of CRC recurrence after surgery is important, as it may increase the chance of curative (ability to cure) outcomes for patients with cancer recurrence. Currently, the Signatera assay is used to monitor whether CRC recurs after surgery, however it is not a very sensitive test. Early work with the Haystack assay suggests it may be more sensitive than the Signatera assay, which may be more effective for the early detection of cancer recurrence in patients with resectable stage II-IV CRC.
Trial Details
NCT Number NCT07125729
Lead Sponsor City of Hope Medical Center
Collaborators: National Cancer Institute (NCI)
Conditions Resectable Colorectal Carcinoma, Stage II Colorectal Cancer AJCC v8, Stage III Colorectal Cancer AJCC v8, Stage IV Colorectal Cancer AJCC v8
Enrollment 150 participants
Start Date 2025-08-29
Primary Completion 2028-01-09 (estimated)
Study Completion 2028-01-09 (estimated)
Updated on ClinicalTrials.gov 2026-08-12