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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-12

Study Completion Date

2028-01-09

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

CORRECT Study of Minimal Residual Disease Detection in Colorectal Cancer

NCT05210283

Colorectal Cancer

ACTIVE_NOT_RECRUITING

Exosome-based Detection of Molecular Residual Disease in Stage II-III Colorectal Cancer

NCT06654622

Colo-rectal Cancer Colorectal Cancer Recurrent

RECRUITING

A Phase 2 Trial of Fruquintinib and Tislelizumab in ctDNA-defined Minimal Residual Disease in Colorectal Cancer After Completion of Adjuvant Chemotherapy

NCT07136077

Minimal Residual Disease Adjuvant Chemotherapy Colorectal Cancer +3 more

ACTIVE_NOT_RECRUITING PHASE2

First CORRECT Study of Minimal Residual Disease (MRD) Detection in Colorectal Cancer

NCT06398743

Colorectal Cancer

ACTIVE_NOT_RECRUITING

Stage II/III Colorectal Cancer Recurrence

NCT06314958

Colorectal Cancer Colorectal Adenocarcinoma Colorectal Cancer Stage II +2 more

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

PRIMARY OBJECTIVE:

I. To compare the clinical performance of the Haystack MRD test and the Signatera® test in patients with stage II-IV CRC patients treated with curative intent surgery with or without adjuvant therapy.

SECONDARY OBJECTIVE:

I. To calculate the lead time (months) of recurrence detection by the Haystack MRD test in curatively resected colorectal cancer patients to 1) radiological recurrence time 2) Signatera® test positivity.

EXPLORATORY OBJECTIVE:

I. To explore the performance of up to two cancer detection assays (BestSEEK and enACT) in development by Dr. Tomasetti at City of Hope - Translational Genomics Research Institute (TGen) and City of Hope.

OUTLINE:

Patients undergo archival tissue and blood sample collection and Haystack MRD and Signatera circulating tumor deoxyribonucleic acid (ctDNA)/cell-free deoxyribonucleic acid (cfDNA) testing prior to standard of care (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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Biospecimen Collection

Intervention Type PROCEDURE

Undergo archival tissue and/or blood sample collection

cfDNA or ctDNA Measurement

Intervention Type OTHER

Undergo Haystack MRD and Signatera ctDNA/cfDNA testing

Electronic Health Record Review

Intervention Type OTHER

Ancillary studies

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Biospecimen Collection

Undergo archival tissue and/or blood sample collection

Intervention Type PROCEDURE

cfDNA or ctDNA Measurement

Undergo Haystack MRD and Signatera ctDNA/cfDNA testing

Intervention Type OTHER

Electronic Health Record Review

Ancillary studies

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Biological Sample Collection Biospecimen Collected Specimen Collection Cell-Free DNA/Circulating Tumor DNA Measurement cfDNA/ctdDNA Measurement cfDNA/ctDNA cfDNA/ctDNA Measurement Circulating Cell-Free DNA/Circulating Tumor-Derived DNA Measurement

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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