Comparing Haystack and Signatera Blood Tests for Early Detection of Cancer Return in Patients with Stage II-IV Colorectal Cancer After Surgery

What this Trial Is About

Researchers are studying patients with stage II-IV colorectal cancer CRC that can be removed by surgery to compare two blood tests, the Haystack MRD test and the Signatera assay, for detecting if the cancer returns after treatment. The study aims to find if the Haystack test can detect cancer recurrence earlier and more sensitively than the currently used Signatera test. Early detection of cancer return is important to improve chances for curative treatment in these patients. Participants will provide tissue and blood samples before surgery and then undergo both Haystack MRD and Signatera ctDNAcfDNA testing several times after surgery. Testing occurs 3 to 10 weeks post-surgery, then every 3 months for the first two years, and every 6 months for years three to five if no disease progression is observed. The study also explores the performance of two additional cancer detection assays under development. Throughout the study, participants will have blood samples collected at regular intervals and archival tissue accessed for personalized testing. Researchers will monitor minimal residual disease rates, the timing of cancer recurrence detection by the tests and imaging, and associations between ctDNA results and recurrence status over a follow-up period of up to five years. This long-term monitoring aims to assess the clinical performance and lead time advantages of the Haystack test compared to Signatera.

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