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Minimal Residual Disease Testing for Colorectal Cancer Recurrence

This study is looking at two different blood tests, Haystack and Signatera®, to see how well they can find small amounts of cancer that might be left after surgery for colorectal cancer. This is called minimal residual disease (MRD). Finding MRD early could help doctors know if the cancer is coming back sooner, which might improve the chances of successful treatment. You could be eligible if you are 18 or older and have stage II, III, or IV colorectal cancer that can be removed by surgery. The study will compare how well Haystack and Signatera® detect MRD over five years. The goal is to see if one test is better at finding cancer recurrence early.

Study design
This study plans to enroll 150 participants with resectable stage II-IV colorectal cancer. It is an interventional study, but the phase is not specified.
What's involved
You would provide archival tissue and blood samples before surgery. After surgery, you would have blood samples taken and tested every 3 months for 2 years, then every 6 months for years 3-5.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 5 years to measure minimal residual disease.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07125729

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

Recruiting
NAAges 18+InterventionalScreening
City of Hope Medical Center
~150 participants
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:Biospecimen CollectioncfDNA or ctDNA MeasurementElectronic Health Record Review

At a glance

Recruiting sites
13 of 13 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Minimal residual disease (MRD) rate with Haystack and Signatera®
Measured over Up to 5 years

Conditions

Resectable Colorectal Carcinoma
Stage II Colorectal Cancer AJCC v8
Stage III Colorectal Cancer AJCC v8
Stage IV Colorectal Cancer AJCC v8

Explore related trials

Colorectal Carcinoma

Where it's being run

13 sites across 4 states
California10
Arizona1
Georgia1
Illinois1

Study leadership

  • Marwan G Fakih · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center

Who to contact

Marwan G. Fakih
[email protected]
626-613-5025
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Minimal residual disease (MRD) rate with Haystack and Signatera®Up to 5 years

    Will assess the MRD rate with Haystack (positive circulating tumor deoxyribonucleic acid \[+ctDNA\] and negative imaging) versus MRD rate with Signatera (+ctDNA and negative imaging). Sensitivity (i.e., true positive rate - proportion of patients who recur that are found to be MRD positive), specificity (i.e., true negative rate - proportion of patients who do NOT recur that are found to be MRD negative), positive predictive value (i.e., proportion of positive tests which are true positives) and negative predictive value (proportion of negative tests which are true negatives) of the Haystack test and of the Signatera test for predicting disease recurrence will be calculated and summarized at various times of testing.