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Minimal Residual Disease Testing for the Early Detection of Cancer Recurrence in Resectable Stage II-IV Colorectal Cancer Patients
Sponsor: City of Hope Medical Center
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.
Official title: ctDNA Testing in Resectable Stage II-IV Colorectal Cancer Patients: A Head-to-Head Performance Comparison
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2025-07-12
Completion Date
2028-01-09
Last Updated
2025-08-15
Healthy Volunteers
No
Conditions
Interventions
Biospecimen Collection
Undergo archival tissue and/or blood sample collection
cfDNA or ctDNA Measurement
Undergo Haystack MRD and Signatera ctDNA/cfDNA testing
Electronic Health Record Review
Ancillary studies
Locations (13)
CTCA at Western Regional Medical Center
Goodyear, Arizona, United States
City of Hope Corona
Corona, California, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
City of Hope Seacliff
Huntington Beach, California, United States
City of Hope at Irvine Lennar
Irvine, California, United States
City of Hope Antelope Valley
Lancaster, California, United States
City of Hope at Long Beach Elm
Long Beach, California, United States
City of Hope at Newport Beach Fashion Island
Newport Beach, California, United States
City of Hope South Pasadena
South Pasadena, California, United States
City of Hope South Bay
Torrance, California, United States
City of Hope Upland
Upland, California, United States
City of Hope Atlanta Cancer Center
Newnan, Georgia, United States
City of Hope at Chicago
Zion, Illinois, United States