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RECRUITING
NCT07125729
NA

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

View on ClinicalTrials.gov

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

Interventions

PROCEDURE

Biospecimen Collection

Undergo archival tissue and/or blood sample collection

OTHER

cfDNA or ctDNA Measurement

Undergo Haystack MRD and Signatera ctDNA/cfDNA testing

OTHER

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