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

Recruiting now · Not applicable

Conditions studied: Resectable Colorectal Carcinoma, Stage II Colorectal Cancer AJCC v8, Stage III Colorectal Cancer AJCC v8, Stage IV Colorectal Cancer AJCC v8

In brief

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.

Key facts

Study ID: NCT07125729
Run by: City of Hope Medical Center
People needed: 150
Starts: 2025-07-12
Expected to finish: 2028-01-09
Last updated by the study team: 2025-08-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

Inability to safely provide sequential blood samples
Clinical evidence of unresected metastatic disease
Inability to give informed consent

Where it is running

CTCA at Western Regional Medical Center — Goodyear, Arizona, United States (enrolling)
City of Hope Corona — Corona, California, United States (enrolling)
City of Hope Comprehensive Cancer Center — Duarte, California, United States (enrolling)
City of Hope Seacliff — Huntington Beach, California, United States (enrolling)
City of Hope at Irvine Lennar — Irvine, California, United States (enrolling)
City of Hope Antelope Valley — Lancaster, California, United States (enrolling)
City of Hope at Long Beach Elm — Long Beach, California, United States (enrolling)
City of Hope at Newport Beach Fashion Island — Newport Beach, California, United States (enrolling)
City of Hope South Pasadena — South Pasadena, California, United States (enrolling)
City of Hope South Bay — Torrance, California, United States (enrolling)
City of Hope Upland — Upland, California, United States (enrolling)
City of Hope Atlanta Cancer Center — Newnan, Georgia, United States (enrolling)
City of Hope at Chicago — Zion, Illinois, United States (enrolling)

Full record on ClinicalTrials.gov

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