Actively Recruiting
Minimal Residual Disease Testing for the Early Detection of Cancer Recurrence in Resectable Stage II-IV Colorectal Cancer Patients
Led by City of Hope Medical Center · Updated on 2025-08-15
150
Participants Needed
13
Research Sites
130 weeks
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Minimal Residual Disease Testing for the Early Detection of Cancer Recurrence in Resectable Stage II-IV Colorectal Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent
- Be 18 years of age or older
- Have a diagnosis of stage II, III, or IV colorectal cancer if enrolled after surgery
- Be scheduled for curative intent surgery or have already had curative surgery and are in surveillance
- Be considered an appropriate candidate for Signatera4 testing as standard care MRD surveillance
- Be willing to continue Signatera4 testing every 3 months for 2 years and every 6 months for years 3 to 5 after surgery
- Be willing to provide blood samples for Haystack MRD testing at the same intervals as Signatera4
- Allow access to archival tissue for Haystack MRD test personalization
- Have adequate archival or viable tissue available for testing
- Patients with total neoadjuvant therapy for rectal cancer and complete clinical response planning watchful waiting may enroll if tissue is adequate
You will not qualify if you...
- Unable to safely provide sequential blood samples
- Have clinical evidence of unresected metastatic disease
- Unable to give informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
CTCA at Western Regional Medical Center
Goodyear, Arizona, United States, 85338
Actively Recruiting
2
City of Hope Corona
Corona, California, United States, 92882
Actively Recruiting
3
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010
Actively Recruiting
4
City of Hope Seacliff
Huntington Beach, California, United States, 92648
Actively Recruiting
5
City of Hope at Irvine Lennar
Irvine, California, United States, 92618
Actively Recruiting
6
City of Hope Antelope Valley
Lancaster, California, United States, 93534
Actively Recruiting
7
City of Hope at Long Beach Elm
Long Beach, California, United States, 90813
Actively Recruiting
8
City of Hope at Newport Beach Fashion Island
Newport Beach, California, United States, 92660
Actively Recruiting
9
City of Hope South Pasadena
South Pasadena, California, United States, 91030
Actively Recruiting
10
City of Hope South Bay
Torrance, California, United States, 90503
Actively Recruiting
11
City of Hope Upland
Upland, California, United States, 91786
Actively Recruiting
12
City of Hope Atlanta Cancer Center
Newnan, Georgia, United States, 30265
Actively Recruiting
13
City of Hope at Chicago
Zion, Illinois, United States, 60099
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SCREENING
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here