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

Launched by CITY OF HOPE MEDICAL CENTER · Aug 10, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new blood test called the Haystack assay to see if it can better detect early signs that colorectal cancer (a type of cancer in the colon or rectum) might be coming back after surgery. The test looks for tiny traces of cancer cells that remain in the body, called minimal residual disease (MRD), which are too small to be seen on scans. Detecting these early signs can help doctors act sooner and improve the chances of curing the cancer if it does return. The study compares the Haystack test to a currently used test called Signatera®, which is known but may not be sensitive enough to catch cancer coming back as early as possible.

Adults aged 18 and older who have stage II, III, or IV colorectal cancer that can be removed by surgery may be eligible to join. This includes patients who have already had surgery or those about to have surgery with plans to remove the cancer. Participants need to be willing to have regular blood tests every few months for up to five years after surgery, which will be used to monitor for signs of cancer returning using both the new Haystack test and the standard Signatera® test. The study also requires access to tumor tissue samples to personalize the tests. If you are interested, doctors will review your medical history and discuss if this trial might be right for you. The goal is to find better ways to catch cancer early and improve long-term outcomes for people with colorectal cancer.

Gender

ALL

Eligibility 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