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

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

The CORRECT - MRD I study will prospectively enroll patients who have undergone complete surgical resection for stage II or III colorectal cancer. Patients will be followed for up to 5 years for recurrence.

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 416

Contacts and Locations

Study Locations

• Israel
  • Afula, Israel, 1834111
    • HaEmek Medical Center
  • Jerusalem, Israel, 12000
    • Hadassah University Hospital - Mount Scopus
  • Jerusalem, Israel, 9312584
    • Shaare Zedek Medical Center Jerusalem
  • Hadarom
    • Be'er Sheva, Hadarom, Israel, 8410101
      • Soroka University Medical Center
  • Hamerkaz
    • Tel Aviv Yaffo, Hamerkaz, Israel, 64239
      • Tel Aviv Sourasky Medical Center
  • North
    • Hadera, North, Israel, 3846201
      • Hillel Yaffe Medical Center
• Italy
  • Milano, Italy, 20262
    • Asst Grande Ospedale Metropolitano Niguarda
  • Napoli, Italy, 20162
    • Istituto Nazionale Tumori - Fondazione G Pascale
  • Milano
    • Rozzano, Milano, Italy, 20089
      • Istituto Clinico Humanitas
• Japan
  • Kita-gun, Japan, 7610793
    • Kagawa University Hospital
  • Chiba
    • Kashiwa, Chiba, Japan, 277-8577
      • National Cancer Center Hospital East
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 003-0804
      • Hokkaido Cancer Center
• Spain
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Madrid, Spain, 28050
    • Centro Integral Oncologico Clara Campal (HM CIOCC)
• United Kingdom
  • Ipswich, United Kingdom, IP4 5PD
    • Ipswich Hospital
  • Kidderminster, United Kingdom, DY11 6RJ
    • Kidderminster Hospital and Treatment Centre
  • Redditch, United Kingdom, B98 7UB
    • Alexandra Hospital
  • Torquay, United Kingdom, TQ2 7AA
    • Torbay Hospital
  • Oxford
    • Headington, Oxford, United Kingdom, OX3 7LE
      • Churchill Hospital
  • Scotland
    • Edinburgh, Scotland, United Kingdom, EH4 3NQ
      • Edinburgh Cancer Centre
  • West Midlands
    • Birmingham, West Midlands, United Kingdom, B15 2TH
      • Queen Elizabeth Hospital Birmingham
  • Worcestershire
    • Worcester, Worcestershire, United Kingdom, WR5 1DD
      • Worcestershire Royal Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 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:

Subject is/has:

1. 18 years of age or older.
2. Diagnosis of carcinoma of the colon or rectum (patients with lymphomatous, sarcomatous,or neuroendocrine features are not eligible).

3. 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 form 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.

4. Pathologic Stage II or III CRC.
5. ECOG performance status ≤ 2 (0, 1 or 2).
6. Able to understand and provide written informed consent.
7. Willing and able to comply with the study requirements, which includes the collection of approximately 35mL of blood for each research blood draw.

Exclusion Criteria:

Subject is/has:

1. Initiated adjuvant therapy for current CRC diagnosis (note: neoadjuvant therapy acceptable).
2. Known pregnancy 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?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To validate the association of post-definitive therapy and pre-recurrence follow-up ctDNA positivity with Recurrence Free Interval, defined as elapsed time from surgical resection to the first clinical recurrence or CRC-related death.	6 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Time from the first ctDNA positivity to recurrence among subjects who have a positive ctDNA finding and have recurred.	6 years

Collaborators and Investigators

• Sponsor: Exact Sciences Corporation
• Collaborators: Fortrea
• Investigators: Study Director: Somasundaram Subramaniam, MD, Exact Sciences

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2023
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: April 24, 2024
• First Submitted That Met QC Criteria: May 1, 2024
• First Posted (Actual): May 3, 2024

Study Record Updates

• Last Update Posted (Actual): July 24, 2025
• Last Update Submitted That Met QC Criteria: July 21, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: ctDNA; Colorectal
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Neoplastic Processes; Colorectal Neoplasms; Neoplasm, Residual
• Other Study ID Numbers: 16-001

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/independent ethics committee 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: No
• product manufactured in and exported from the U.S.: No