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

CORRECT-MRD II: Second Colorectal Cancer Clinical Validation Study to Predict Recurrence Using a Circulating Tumor DNA Assay to Detect Minimal Residual Disease

The CORRECT - MRD II study will prospectively enroll patients who have undergone complete surgical resection for stage II or III colorectal cancer. Maximum duration of participant participation is up to seven years from enrollment to study completion with up to five years of active follow up and up to two years of clinical (passive) follow up.

Study Overview

• Status: Active, not recruiting
• Conditions: Colorectal Cancer
• Intervention / Treatment: Device: MRD

• Study Type: Observational
• Enrollment (Actual): 1017

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G1Z2
      • Cross Cancer Institute
  • Ontario
    • Toronto, Ontario, Canada, M5G2C1
      • Princess Margaret Cancer Center
  • Quebec
    • Montreal, Quebec, Canada, H3T1E2
      • Jewish General Hospital
    • Montreal, Quebec, Canada, H4A3J1
      • McGill University Health - Glen Site
• United States
  • California
    • Mission Hills, California, United States, 91345
      • Facey Medical Group - Mission Hills - Endoscopy Center & Gastroenterology
    • Torrance, California, United States, 90505
      • Torrance Memorial Hunt Cancer Institute
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida Division of Hematology & Oncology
    • Miami Beach, Florida, United States, 33140
      • Mount Sinai Medical - Comprehensive Cancer Center
    • Orange City, Florida, United States, 32763
      • Mid Florida Cancer Centers
  • Illinois
    • Elmhurst, Illinois, United States, 60126
      • Edward Cancer Center
    • Peoria, Illinois, United States, 61615
      • Illinois Cancer Care
  • Iowa
    • Cedar Rapids, Iowa, United States, 52403
      • Mercy Medical Center
  • Kansas
    • Westwood, Kansas, United States, 66205
      • University of Kansas Cancer Center
  • Maryland
    • Baltimore, Maryland, United States, 21237
      • MedStar Georgetown Cancer Institute at MedStar Georgetown University Hospital
    • Hagerstown, Maryland, United States, 21742
      • Meritus Center for Clinical Research
    • Towson, Maryland, United States, 21093
      • University of Maryland St. Joseph Medical Center
  • Minnesota
    • Saint Louis Park, Minnesota, United States, 55426
      • Metro Minnesota Community Oncology Consortium (MMCORC)
  • Missouri
    • St Louis, Missouri, United States, 63131
      • Missouri Baptist Medical Center
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Atrium Health Levine Cancer Institute
    • Pinehurst, North Carolina, United States, 28374
      • FirstHealth Outpatient Cancer Center
    • Winston-Salem, North Carolina, United States, 27157
      • Atrium Health Wake Forest Baptist Medical Center
  • North Dakota
    • Fargo, North Dakota, United States, 58104
      • Sanford Roger Maris Cancer Center
  • Ohio
    • Columbus, Ohio, United States, 43215
      • Columbus NCORP
  • Oregon
    • Portland, Oregon, United States, 97227
      • Interstate Medical Office Central
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15232
      • UPMC Hillman Cancer Center
    • West Reading, Pennsylvania, United States, 19611
      • Reading Hospital Hematology Oncology
    • Wynnewood, Pennsylvania, United States, 19096
      • Lankenau Medical Center
    • York, Pennsylvania, United States, 17403
      • WellSpan York Cancer Center
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Primsa Health Cancer Institute
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57104
      • Sanford Cancer Center
  • Tennessee
    • Kingsport, Tennessee, United States, 37660
      • Ballad Health Cancer Center
  • Wisconsin
    • Weston, Wisconsin, United States, 54476
      • Marshfield Medical Center Weston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients over the age of 18 who have undergone surgery for stage II or III colorectal cancer

Description

Inclusion Criteria:

1. Diagnosis of carcinoma of the colon or rectum (patients with lymphomatous, sarcomatous, or neuroendocrine features are not eligible).

2. Post complete surgical resection of CRC, with last surgery occurring within 180 days prior to enrollment are eligible if all of the following conditions are met:

   1. in the opinion of the surgeon, all grossly visible tumor was completely resected ("curative resection") and
   2. histologic evaluation by the pathologist confirms the margins of the resected specimens are not involved by malignant cells.

   i. Patients with T4 tumors that have involved an adjacent structure (e.g., bladder, small intestine, ovary, etc.) by direct extension from the primary tumor must have had all or a portion of the adjacent structure removed en bloc with the primary tumor and local radiation therapy will not be utilized.

3. Pathologic stage II or III
4. ECOG performance status ≤ 2 (0, 1 or 2).
5. Able to understand and provide informed consent.
6. Willing and able to comply with the study requirements, which includes the collection of approximately 43mL of blood for each research blood draw.

Exclusion Criteria:

1. Initiated adjuvant therapy for current CRC diagnosis (note: prior neoadjuvant therapy acceptable).
2. Pregnant or breastfeeding at time of enrollment.
3. Prior history of any invasive cancer (including CRC) within the past 3 years prior to informed consent, with the exception of non-melanoma skin cancer. Patients with a prior history of noninvasive (in situ) carcinomas may participate after definitive treatment.

4. Prior transplant history:

   1. Prior allogeneic hematopoietic stem cell transplant at any time.
   2. Prior solid organ transplant within the last 2 years prior to enrollment.
5. Multiple cancer diagnoses: Synchronous or asynchronous diagnoses (or suspicion) of multiple primary cancers at the time of eligibility screening.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Stage ll or lll; Patients with stage ll or lll colorectal cancer	Device: MRD; ctDNA MRD test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To validate the association of circulating tumor DNA (ctDNA) with recurrence-free interval (RFI).	7 years

Secondary Outcome Measures

Outcome Measure	Time Frame
To assess the sensitivity and specificity of ctDNA positivity for subsequent clinical recurrence.	7 years
To assess the contribution of ctDNA on RFI, independent of clinicopathological risk features and other biomarkers	7 years
To assess time from positive ctDNA to clinical recurrence	7 years

Collaborators and Investigators

• Sponsor: Exact Sciences Corporation
• Collaborators: NSABP Foundation Inc

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2021
• Primary Completion (Estimated): May 15, 2027
• Study Completion (Estimated): May 15, 2027

Study Registration Dates

• First Submitted: January 13, 2022
• First Submitted That Met QC Criteria: January 25, 2022
• First Posted (Actual): January 27, 2022

Study Record Updates

• Last Update Posted (Estimated): January 12, 2026
• Last Update Submitted That Met QC Criteria: January 8, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: ctDNA; Colorectal
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 16-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in publications of the study will be shared after deidentification. This may include test, tables, figured, and appendices. The study protocol, statistical analysis plan (when applicable), informed consent form (when applicable). May not be reproduced nor disseminated outside of Exact Sciences without permission and the clinical study report (when applicable) will also be shared
• IPD Sharing Time Frame: Data will be available from 2 years and ending 4 years after publication
• IPD Sharing Access Criteria: Proposals for access to data should be directed to clinicaltrials@exactsciences.com. To gain access, data requestors will need to provide a methodologically sound proposal and sign a data access agreement. Researchers are required to obtain necessary Institutional Review Board (IRB)/Institutional Ethics Committee (IEC) approvals or waivers as applicable to conduct research.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No