RECRUITING

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

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Conditions

Resectable Colorectal CarcinomaStage II Colorectal Cancer AJCC v8Stage III Colorectal Cancer AJCC v8Stage IV Colorectal Cancer AJCC v8

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

ctDNA Testing in Resectable Stage II-IV Colorectal Cancer Patients: A Head-to-Head Performance Comparison

Quick Facts

Study Start:2025-07-12
Study Completion:2028-01-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07125729

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Documented written informed consent of the participant
  2. * Age: ≥ 18 years
  3. * 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
  4. * Patient who are to undergo a curative intent surgery or have undergone a curative resection and are presenting for surveillance
  5. * Patient identified as an appropriate candidate for Signatera® testing as a standard of care MRD surveillance assay
  6. * 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
  7. * 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
  8. * 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
  1. * Inability to safely provide sequential blood samples
  2. * Clinical evidence of unresected metastatic disease
  3. * Inability to give informed consent

Contacts and Locations

Principal Investigator

Marwan G Fakih
PRINCIPAL_INVESTIGATOR
City of Hope Medical Center

Study Locations (Sites)

CTCA at Western Regional Medical Center
Goodyear, Arizona, 85338
United States
City of Hope Corona
Corona, California, 92882
United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
United States
City of Hope Seacliff
Huntington Beach, California, 92648
United States
City of Hope at Irvine Lennar
Irvine, California, 92618
United States
City of Hope Antelope Valley
Lancaster, California, 93534
United States
City of Hope at Long Beach Elm
Long Beach, California, 90813
United States
City of Hope at Newport Beach Fashion Island
Newport Beach, California, 92660
United States
City of Hope South Pasadena
South Pasadena, California, 91030
United States
City of Hope South Bay
Torrance, California, 90503
United States
City of Hope Upland
Upland, California, 91786
United States
City of Hope Atlanta Cancer Center
Newnan, Georgia, 30265
United States
City of Hope at Chicago
Zion, Illinois, 60099
United States

Collaborators and Investigators

Sponsor: City of Hope Medical Center

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-12
Study Completion Date2028-01-09

Study Record Updates

Study Start Date2025-07-12
Study Completion Date2028-01-09

Terms related to this study

Additional Relevant MeSH Terms

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