Comparing two blood tests to find colorectal cancer coming back after surgery
Official title: ctDNA Testing in Resectable Stage II-IV Colorectal Cancer Patients: A Head-to-Head Performance Comparison
Run by City of Hope Medical Center · NCT07125729 · Data updated 2026-11-12
This tests whether the Haystack blood test finds returning colorectal cancer earlier than the Signatera test in adults who have had curative surgery for stage II–IV disease.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | City of Hope Medical Center Academic / other |
| Locations | 13 sites (Goodyear, Arizona and 12 other locations) |
| Status | Recruiting |
| Started | August 29, 2025 |
| Main results expected | January 9, 2028 |
| Study ends | January 9, 2028 |
| Registry record updated | August 12, 2026 |
| Trial ID | NCT07125729 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with resectable stage II–IV colorectal cancer who are candidates for Signatera MRD surveillance and willing to provide tissue and serial blood samples are eligible.
✕Probably not a fit
Patients with stage I disease, unresectable disease, or those unwilling/unable to attend participating centers and follow the serial blood-draw schedule are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Patients who have had or will have curative-intent surgery for stage II–IV colorectal cancer will provide archival tumor tissue and blood samples for paired ctDNA/cfDNA testing with the Haystack and Signatera assays. Blood is collected before surgery, 3–10 weeks after surgery, every 3 months for the first 2 years, and every 6 months through year 5 unless disease progresses. The primary goal is to compare the clinical performance (sensitivity/specificity) of Haystack versus Signatera for detecting minimal residual disease. Secondary analyses include calculating how many months earlier Haystack detects recurrence compared with radiology and Signatera, with exploratory testing of additional developmental assays.
Why it matters
Potential benefit: If successful, a more sensitive blood test could detect recurrence earlier and increase the chance that recurrent disease is treated curatively.
How similar studies have gone: Signatera is already used clinically for MRD surveillance but has limited sensitivity, and early data suggest Haystack may be more sensitive, though this approach is still relatively novel and requires confirmation.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Documented written informed consent of the participant * Age: ≥ 18 years * Diagnosis of stage II, III or IV colorectal cancer (any gender) if enrolled post-operatively. If a treatment naïve patient is enrolled pre-operatively and determined to be pathological stage I, the patient will be replaced * Patient who are to undergo a curative intent surgery or have undergone a curative resection and are presenting for surveillance * Patient identified as an appropriate candidate for Signatera® testing as a standard of care MRD surveillance assay * Patient willingness to continue Signatera® assay every 3 months for 2 years in the first 2 years after resection and every 6 months for years 3, 4, 5 after resection, as performed by standard of care testing. In addition, the patients should be willing to provide blood samples for Haystack MRD testing at the same intervals of Signatera®, along with willingness to allow access to archival tissue to allow for Haystack MRD assay personalization. Surveillance with ctDNA should be initiated between 3 to 10 weeks from surgery * Adequate availability of archival tissue or anticipated pathological viable tissue. All untreated primary resection would be expected to have adequate tissue. Patients with resected metastatic disease should have either previously resected primary that is amenable for tumor informed MRD testing or should have adequate archival metastasectomy samples * Patients with total neoadjuvant therapy (TNT) for rectal cancer and complete clinical response with plans of watchful waiting may also be enrolled as long as there is adequate tissue from prior endoscopic biopsies to allow for Signatera® and Haystack MRD assays Exclusion Criteria: * Inability to safely provide sequential blood samples * Clinical evidence of unresected metastatic disease * Inability to give informed consent
Where it's running
-
CTCA at Western Regional Medical Center
Goodyear, Arizona, United States Recruiting -
City of Hope Corona
Corona, California, United States Recruiting -
City of Hope Comprehensive Cancer Center
Duarte, California, United States Recruiting -
City of Hope Seacliff
Huntington Beach, California, United States Recruiting -
City of Hope at Irvine Lennar
Irvine, California, United States Recruiting -
City of Hope Antelope Valley
Lancaster, California, United States Recruiting
Show 7 more locations
-
City of Hope at Long Beach Elm
Long Beach, California, United States Recruiting -
City of Hope at Newport Beach Fashion Island
Newport Beach, California, United States Recruiting -
City of Hope South Pasadena
South Pasadena, California, United States Recruiting -
City of Hope South Bay
Torrance, California, United States Recruiting -
City of Hope Upland
Upland, California, United States Recruiting -
City of Hope Atlanta Cancer Center
Newnan, Georgia, United States Recruiting -
City of Hope at Chicago
Zion, Illinois, United States Recruiting
Study contacts
- Principal investigator: Marwan G Fakih — City of Hope Medical Center
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Family genetics: who shares test results with relatives
This study tests whether letting patients share genetic results with their relatives is as good as doctors sharing the results to help first-degree relatives get genetic testing for hereditary cancer risk.
-
Combining botensilimab and balstilimab after standard treatment for colorectal cancer
This phase 2 trial tests whether giving botensilimab and balstilimab after standard therapy can clear detectable ctDNA in adults with stage II/III colorectal cancer.
-
Zanidatamab given before surgery for HER2-positive colon or rectal cancer
This tests whether giving zanidatamab before surgery helps adults with HER2-positive, RAS‑wildtype colon or rectal cancer who are planned for curative treatment.
-
Pidnarulex plus cemiplimab for refractory microsatellite-stable colorectal cancer.
This tests whether combining pidnarulex with cemiplimab is safe and can help people whose microsatellite-stable colorectal cancer has stopped responding to standard treatments.
-
Helping colorectal cancer survivors keep up with post-surgery surveillance
This project tests whether patient navigation services, an interactive web program called Current Together After Cancer (CTAC), or both help people with stage I–III colorectal cancer keep up with recommended post-surgery surveillance.
-
Combining CA-4948 with chemotherapy for metastatic colorectal cancer
This study is testing a new drug called CA-4948 combined with chemotherapy to see if it can safely help people with metastatic colorectal cancer.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.