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
1 other identifier
observational
1,017
2 countries
32
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2021
Longer than P75 for all trials
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 15, 2021
CompletedFirst Submitted
Initial submission to the registry
January 13, 2022
CompletedFirst Posted
Study publicly available on registry
January 27, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 15, 2027
January 12, 2026
January 1, 2026
5.4 years
January 13, 2022
January 8, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To validate the association of circulating tumor DNA (ctDNA) with recurrence-free interval (RFI).
7 years
Secondary Outcomes (3)
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
Study Arms (1)
Stage ll or lll
Patients with stage ll or lll colorectal cancer
Interventions
Eligibility Criteria
Patients over the age of 18 who have undergone surgery for stage II or III colorectal cancer
You may qualify if:
- Diagnosis of carcinoma of the colon or rectum (patients with lymphomatous, sarcomatous, or neuroendocrine features are not eligible).
- 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:
- in the opinion of the surgeon, all grossly visible tumor was completely resected ("curative resection") and
- 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.
- Pathologic stage II or III
- ECOG performance status ≤ 2 (0, 1 or 2).
- Able to understand and provide informed consent.
- Willing and able to comply with the study requirements, which includes the collection of approximately 43mL of blood for each research blood draw.
You may not qualify if:
- Initiated adjuvant therapy for current CRC diagnosis (note: prior neoadjuvant therapy acceptable).
- Pregnant or breastfeeding at time of enrollment.
- 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.
- Prior transplant history:
- Prior allogeneic hematopoietic stem cell transplant at any time.
- Prior solid organ transplant within the last 2 years prior to enrollment.
- Multiple cancer diagnoses: Synchronous or asynchronous diagnoses (or suspicion) of multiple primary cancers at the time of eligibility screening.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Exact Sciences Corporationlead
- NSABP Foundation Inccollaborator
Study Sites (32)
Facey Medical Group - Mission Hills - Endoscopy Center & Gastroenterology
Mission Hills, California, 91345, United States
Torrance Memorial Hunt Cancer Institute
Torrance, California, 90505, United States
University of Florida Division of Hematology & Oncology
Gainesville, Florida, 32610, United States
Mount Sinai Medical - Comprehensive Cancer Center
Miami Beach, Florida, 33140, United States
Mid Florida Cancer Centers
Orange City, Florida, 32763, United States
Edward Cancer Center
Elmhurst, Illinois, 60126, United States
Illinois Cancer Care
Peoria, Illinois, 61615, United States
Mercy Medical Center
Cedar Rapids, Iowa, 52403, United States
University of Kansas Cancer Center
Westwood, Kansas, 66205, United States
MedStar Georgetown Cancer Institute at MedStar Georgetown University Hospital
Baltimore, Maryland, 21237, United States
Meritus Center for Clinical Research
Hagerstown, Maryland, 21742, United States
University of Maryland St. Joseph Medical Center
Towson, Maryland, 21093, United States
Metro Minnesota Community Oncology Consortium (MMCORC)
Saint Louis Park, Minnesota, 55426, United States
Missouri Baptist Medical Center
St Louis, Missouri, 63131, United States
Atrium Health Levine Cancer Institute
Charlotte, North Carolina, 28204, United States
FirstHealth Outpatient Cancer Center
Pinehurst, North Carolina, 28374, United States
Atrium Health Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157, United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58104, United States
Columbus NCORP
Columbus, Ohio, 43215, United States
Interstate Medical Office Central
Portland, Oregon, 97227, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
Reading Hospital Hematology Oncology
West Reading, Pennsylvania, 19611, United States
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096, United States
WellSpan York Cancer Center
York, Pennsylvania, 17403, United States
Primsa Health Cancer Institute
Greenville, South Carolina, 29605, United States
Sanford Cancer Center
Sioux Falls, South Dakota, 57104, United States
Ballad Health Cancer Center
Kingsport, Tennessee, 37660, United States
Marshfield Medical Center Weston
Weston, Wisconsin, 54476, United States
Cross Cancer Institute
Edmonton, Alberta, T6G1Z2, Canada
Princess Margaret Cancer Center
Toronto, Ontario, M5G2C1, Canada
Jewish General Hospital
Montreal, Quebec, H3T1E2, Canada
McGill University Health - Glen Site
Montreal, Quebec, H4A3J1, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 13, 2022
First Posted
January 27, 2022
Study Start
December 15, 2021
Primary Completion (Estimated)
May 15, 2027
Study Completion (Estimated)
May 15, 2027
Last Updated
January 12, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Data will be available from 2 years and ending 4 years after publication
- 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.
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