RecruitingNot ApplicableNCT07125729

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

ctDNA Testing in Resectable Stage II-IV Colorectal Cancer Patients: A Head-to-Head Performance Comparison


Sponsor

City of Hope Medical Center

Enrollment

150 participants

Start Date

Jul 12, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a blood test that detects tiny amounts of cancer DNA (called minimal residual disease or MRD testing) can identify early signs that colorectal cancer has come back after surgery, before it shows up on standard imaging. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with stage II, III, or IV colorectal cancer - You have had or are scheduled to have surgery intended to remove all the cancer (curative intent) **You may NOT be eligible if...** - Your cancer is stage I (very early, low risk) — you would be removed from the study if found to be stage I - You are not undergoing or have not undergone surgical treatment - You have not provided written informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiospecimen Collection

Undergo archival tissue and/or blood sample collection

OTHERcfDNA or ctDNA Measurement

Undergo Haystack MRD and Signatera ctDNA/cfDNA testing

OTHERElectronic 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

View Full Details on ClinicalTrials.gov

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NCT07125729


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