CORRECT Study of Minimal Residual Disease Detection in Colorectal Cancer

NCT ID: NCT05210283

Last Updated: 2026-01-12

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

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

1017 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-15

Study Completion Date

2027-05-15

Brief Summary

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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.

Detailed Description

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Conditions

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Colorectal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Stage ll or lll

Patients with stage ll or lll colorectal cancer

MRD

Intervention Type DEVICE

ctDNA MRD test

Interventions

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MRD

ctDNA MRD test

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NSABP Foundation Inc

NETWORK

Sponsor Role collaborator

Exact Sciences Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Facey Medical Group - Mission Hills - Endoscopy Center & Gastroenterology

Mission Hills, California, United States

Site Status

Torrance Memorial Hunt Cancer Institute

Torrance, California, United States

Site Status

University of Florida Division of Hematology & Oncology

Gainesville, Florida, United States

Site Status

Mount Sinai Medical - Comprehensive Cancer Center

Miami Beach, Florida, United States

Site Status

Mid Florida Cancer Centers

Orange City, Florida, United States

Site Status

Edward Cancer Center

Elmhurst, Illinois, United States

Site Status

Illinois Cancer Care

Peoria, Illinois, United States

Site Status

Mercy Medical Center

Cedar Rapids, Iowa, United States

Site Status

University of Kansas Cancer Center

Westwood, Kansas, United States

Site Status

MedStar Georgetown Cancer Institute at MedStar Georgetown University Hospital

Baltimore, Maryland, United States

Site Status

Meritus Center for Clinical Research

Hagerstown, Maryland, United States

Site Status

University of Maryland St. Joseph Medical Center

Towson, Maryland, United States

Site Status

Metro Minnesota Community Oncology Consortium (MMCORC)

Saint Louis Park, Minnesota, United States

Site Status

Missouri Baptist Medical Center

St Louis, Missouri, United States

Site Status

Atrium Health Levine Cancer Institute

Charlotte, North Carolina, United States

Site Status

FirstHealth Outpatient Cancer Center

Pinehurst, North Carolina, United States

Site Status

Atrium Health Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States

Site Status

Sanford Roger Maris Cancer Center

Fargo, North Dakota, United States

Site Status

Columbus NCORP

Columbus, Ohio, United States

Site Status

Interstate Medical Office Central

Portland, Oregon, United States

Site Status

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Site Status

Reading Hospital Hematology Oncology

West Reading, Pennsylvania, United States

Site Status

Lankenau Medical Center

Wynnewood, Pennsylvania, United States

Site Status

WellSpan York Cancer Center

York, Pennsylvania, United States

Site Status

Primsa Health Cancer Institute

Greenville, South Carolina, United States

Site Status

Sanford Cancer Center

Sioux Falls, South Dakota, United States

Site Status

Ballad Health Cancer Center

Kingsport, Tennessee, United States

Site Status

Marshfield Medical Center Weston

Weston, Wisconsin, United States

Site Status

Cross Cancer Institute

Edmonton, Alberta, Canada

Site Status

Princess Margaret Cancer Center

Toronto, Ontario, Canada

Site Status

Jewish General Hospital

Montreal, Quebec, Canada

Site Status

McGill University Health - Glen Site

Montreal, Quebec, Canada

Site Status

Countries

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United States Canada

Other Identifiers

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16-002

Identifier Type: -

Identifier Source: org_study_id

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