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Active, not recruiting Observational

CORRECT Study of Minimal Residual Disease Detection in Colorectal Cancer

NCT05210283 · tracked via the Priya Life Science Canada tracker
Phase
Observational
Started
2021-12-15
Last updated
2026-01-12

Condition(s) studied

Colorectal Cancer

Investigational drug(s) / intervention(s)

MRD

MRD: ctDNA MRD test

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • To validate the association of circulating tumor DNA (ctDNA) with recurrence-free interval (RFI). — 7 years

Trial sites (32)

FacilityCityRegionStatus
Facey Medical Group - Mission Hills - Endoscopy Center & Gastroenterology Mission Hills California
Torrance Memorial Hunt Cancer Institute Torrance California
University of Florida Division of Hematology & Oncology Gainesville Florida
Mount Sinai Medical - Comprehensive Cancer Center Miami Beach Florida
Mid Florida Cancer Centers Orange City Florida
Edward Cancer Center Elmhurst Illinois
Illinois Cancer Care Peoria Illinois
Mercy Medical Center Cedar Rapids Iowa
University of Kansas Cancer Center Westwood Kansas
MedStar Georgetown Cancer Institute at MedStar Georgetown University Hospital Baltimore Maryland
Meritus Center for Clinical Research Hagerstown Maryland
University of Maryland St. Joseph Medical Center Towson Maryland
Metro Minnesota Community Oncology Consortium (MMCORC) Saint Louis Park Minnesota
Missouri Baptist Medical Center St Louis Missouri
Atrium Health Levine Cancer Institute Charlotte North Carolina
FirstHealth Outpatient Cancer Center Pinehurst North Carolina
Atrium Health Wake Forest Baptist Medical Center Winston-Salem North Carolina
Sanford Roger Maris Cancer Center Fargo North Dakota
Columbus NCORP Columbus Ohio
Interstate Medical Office Central Portland Oregon
UPMC Hillman Cancer Center Pittsburgh Pennsylvania
Reading Hospital Hematology Oncology West Reading Pennsylvania
Lankenau Medical Center Wynnewood Pennsylvania
WellSpan York Cancer Center York Pennsylvania
Primsa Health Cancer Institute Greenville South Carolina
Sanford Cancer Center Sioux Falls South Dakota
Ballad Health Cancer Center Kingsport Tennessee
Marshfield Medical Center Weston Weston Wisconsin
Cross Cancer Institute Edmonton Alberta
Princess Margaret Cancer Center Toronto Ontario
Jewish General Hospital Montreal Quebec
McGill University Health - Glen Site Montreal Quebec
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05210283 on ClinicalTrials.gov ↗ ← All trials in Canada