RECRUITING

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

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.

Study Overview

Study Details

Study overview

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.

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

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

Condition
Resectable Colorectal Carcinoma
Intervention / Treatment

-

Contacts and Locations

Goodyear

CTCA at Western Regional Medical Center, Goodyear, Arizona, United States, 85338

Corona

City of Hope Corona, Corona, California, United States, 92882

Duarte

City of Hope Comprehensive Cancer Center, Duarte, California, United States, 91010

Huntington Beach

City of Hope Seacliff, Huntington Beach, California, United States, 92648

Irvine

City of Hope at Irvine Lennar, Irvine, California, United States, 92618

Lancaster

City of Hope Antelope Valley, Lancaster, California, United States, 93534

Long Beach

City of Hope at Long Beach Elm, Long Beach, California, United States, 90813

Newport Beach

City of Hope at Newport Beach Fashion Island, Newport Beach, California, United States, 92660

South Pasadena

City of Hope South Pasadena, South Pasadena, California, United States, 91030

Torrance

City of Hope South Bay, Torrance, California, United States, 90503

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.

For general information about clinical research, read Learn About Studies.

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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

City of Hope Medical Center,

Marwan G Fakih, PRINCIPAL_INVESTIGATOR, City of Hope Medical Center

Study Record Dates

2028-01-09