Comparing two blood tests to find colorectal cancer coming back after surgery
ctDNA Testing in Resectable Stage II-IV Colorectal Cancer Patients: A Head-to-Head Performance Comparison
NA · City of Hope Medical Center · NCT07125729
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | City of Hope Medical Center (other) |
| Locations | 13 sites (Goodyear, Arizona and 12 other locations) |
| Trial ID | NCT07125729 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Goodyear, Arizona and 12 other locations
- 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)
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Resectable Colorectal Carcinoma, Stage II Colorectal Cancer AJCC v8, Stage III Colorectal Cancer AJCC v8, Stage IV Colorectal Cancer AJCC v8