Recruiting

MRD Testing vs. Signatera

Sponsor:

City of Hope Medical Center

Code:

NCT07125729

Conditions

Resectable Colorectal Carcinoma

Stage II Colorectal Cancer AJCC v8

Stage III Colorectal Cancer AJCC v8

Stage IV Colorectal Cancer AJCC v8

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

cfDNA or ctDNA Measurement

Electronic Health Record Review

Study Details

Brief summary:

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.

Conditions

Resectable Colorectal Carcinoma

Stage II Colorectal Cancer AJCC v8

Stage III Colorectal Cancer AJCC v8

Stage IV Colorectal Cancer AJCC v8

Study ID

NCT07125729

Start date

Aug 29, 2025

Status verified date

Aug, 2026

Completion date

Jan 9, 2028

Anticipated

Primary completion date

Jan 9, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

150 participants

Anticipated

Intervention Model

Single group

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: Screening (Haystack MRD, Signatera)

Patients undergo archival tissue and blood sample collection and Haystack MRD and Signatera ctDNA/cfDNA testing prior SOC surgical resection. Patients then undergo blood sample collection and Haystack MRD and Signatera ctDNA/cfDNA testing 3-10 weeks after surgery, every 3 months for 2 years post-surgery, and then every 6 months for years 3-5 post-surgery in the absence of disease progression.

Interventions

Biospecimen Collection

Undergo archival tissue and/or blood sample collection

cfDNA or ctDNA Measurement

Undergo Haystack MRD and Signatera ctDNA/cfDNA testing

Electronic Health Record Review

Ancillary studies

Primary outcome measure

  • Minimal residual disease (MRD) rate with Haystack and Signatera® [ Time Frame: Up to 5 years ]

Central Contacts and Locations

Locations

CTCA at Western Regional Medical Center

Recruiting

Goodyear, Arizona, United States, 85338

Contacts

Marwan G. Fakih

626-613-5025mfakih@coh.org

Principal Investigator:

Marwan G. Fakih

City of Hope Corona

Recruiting

Corona, California, United States, 92882

Contacts

Marwan G. Fakih

626-613-5025mfakih@coh.org

Principal Investigator:

Marwan G. Fakih

City of Hope Comprehensive Cancer Center

Recruiting

Duarte, California, United States, 91010

Contacts

Marwan G. Fakih

626-613-5025mfakih@coh.org

Principal Investigator:

Marwan G. Fakih

City of Hope Seacliff

Recruiting

Huntington Beach, California, United States, 92648

Contacts

Marwan G. Fakih

626-613-5025mfakih@coh.org

Principal Investigator:

Marwan G. Fakih

City of Hope at Irvine Lennar

Recruiting

Irvine, California, United States, 92618

Contacts

Marwan G. Fakih

626-613-5025mfakih@coh.org

Principal Investigator:

Marwan G. Fakih

City of Hope Antelope Valley

Recruiting

Lancaster, California, United States, 93534

Contacts

Marwan G. Fakih

626-613-5025mfakih@coh.org

Principal Investigator:

Marwan G. Fakih

City of Hope at Long Beach Elm

Recruiting

Long Beach, California, United States, 90813

Contacts

Marwan G. Fakih

626-613-5025mfakih@coh.org

Principal Investigator:

Marwan G. Fakih

City of Hope at Newport Beach Fashion Island

Recruiting

Newport Beach, California, United States, 92660

Contacts

Marwan G. Fakih

626-613-5025mfakih@coh.org

Principal Investigator:

Marwan G. Fakih

City of Hope South Pasadena

Recruiting

South Pasadena, California, United States, 91030

Contacts

Marwan G. Fakih

626-613-5025mfakih@coh.org

Principal Investigator:

Marwan G. Fakih

City of Hope South Bay

Recruiting

Torrance, California, United States, 90503

Contacts

Marwan G. Fakih

626-613-5025mfakih@coh.org

Principal Investigator:

Marwan G. Fakih

City of Hope Upland

Recruiting

Upland, California, United States, 91786

Contacts

Marwan G. Fakih

626-613-5025mfakih@coh.org

Principal Investigator:

Marwan G. Fakih

City of Hope Atlanta Cancer Center

Recruiting

Newnan, Georgia, United States, 30265

Contacts

Marwan G. Fakih

626-613-5025mfakih@coh.org

Principal Investigator:

Marwan G. Fakih

City of Hope at Chicago

Recruiting

Zion, Illinois, United States, 60099

Contacts

Marwan G. Fakih

626-613-5025mfakih@coh.org

Principal Investigator:

Marwan G. Fakih

More Information

Sponsor

City of Hope Medical Center

Last update posted

Aug 12, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by City of Hope Medical Center on 2026-08-12.