Minimal Residual Disease Testing for the Early Detection of Cancer Recurrence in Resectable Stage II-IV Colorectal Cancer Patients
ctDNA Testing in Resectable Stage II-IV Colorectal Cancer Patients: A Head-to-Head Performance Comparison
3 other identifiers
interventional
150
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2025
Typical duration for not_applicable
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 12, 2025
CompletedFirst Submitted
Initial submission to the registry
August 10, 2025
CompletedFirst Posted
Study publicly available on registry
August 15, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 9, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 9, 2028
August 15, 2025
August 1, 2025
2.5 years
August 10, 2025
August 10, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Minimal residual disease (MRD) rate with Haystack and Signatera®
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.
Up to 5 years
Secondary Outcomes (2)
Time interval of detection of disease recurrence by Haystack test, radiological imaging, and Signatera test
Up to 5 years
Level of association of circulating tumor deoxyribonucleic acid (ctDNA) result and status of recurrence and non-recurrence
Up to 5 years
Study Arms (1)
Screening (Haystack MRD, Signatera)
EXPERIMENTALPatients 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
Undergo archival tissue and/or blood sample collection
Undergo Haystack MRD and Signatera ctDNA/cfDNA testing
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Inability to safely provide sequential blood samples
- Clinical evidence of unresected metastatic disease
- Inability to give informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- City of Hope Medical Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (13)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marwan G Fakih
City of Hope Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 10, 2025
First Posted
August 15, 2025
Study Start
July 12, 2025
Primary Completion (Estimated)
January 9, 2028
Study Completion (Estimated)
January 9, 2028
Last Updated
August 15, 2025
Record last verified: 2025-08