CORRECT Study of Minimal Residual Disease Detection in Colorectal Cancer

Recruiting

• Conditions: Colorectal Cancer
• Interventions: Device: MRD

• Registration Number: NCT05210283
• Lead Sponsor: Exact Sciences Corporation

Brief Summary

The CORRECT - MRD II study will prospectively enroll patients who have undergone complete surgical resection for stage II or III colorectal cancer. Patients will be followed for a minimum of 3 years and up to 5 years for recurrence.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-15
• Study First Submitted: 2022-01-13
• Study First Submitted QC: 2022-01-25
• Study First Posted: 2022-01-27
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-01
• Last Update Posted: 2023-02-02
• Primary Completion: 2028-02-15
• Study Completion: 2028-02-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 750

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 written 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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Stage ll or lll	MRD	Patients with stage ll or lll colorectal cancer

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (29)

Levine Cancer Institute; 🇺🇸 Charlotte, North Carolina, United States

McGill University Health Centre-Cedars Cancer Centre; 🇨🇦 Montreal, Quebec, Canada

Illinois Cancer Care; 🇺🇸 Peoria, Illinois, United States

Mercy Medical Center; 🇺🇸 Cedar Rapids, Iowa, United States

Missouri Baptist Medical Center; 🇺🇸 Saint Louis, Missouri, United States

Mount Sinai Medical - Comprehensive Cancer Center; 🇺🇸 Miami Beach, Florida, United States

Lankenau Medical Center; 🇺🇸 Wynnewood, Pennsylvania, United States

Primsa health Cancer Institute - Butternut; 🇺🇸 Greenville, South Carolina, United States

University of Florida; 🇺🇸 Gainesville, Florida, United States

Edwards Cancer Center; 🇺🇸 Elmhurst, Illinois, United States

Providence Facey Medical Foundation; 🇺🇸 Mission Hills, California, United States

Mid Florida Hematology and Oncology Center; 🇺🇸 Orange City, Florida, United States

University of Maryland St. Joseph Medical Center; 🇺🇸 Towson, Maryland, United States

Sanford Cancer Center Oncology Clinic; 🇺🇸 Sioux Falls, South Dakota, United States

Torrance Memorial Medical Center; 🇺🇸 Torrance, California, United States

Medstar Franklin Square; 🇺🇸 Baltimore, Maryland, United States

Medstar Good Samaritan; 🇺🇸 Baltimore, Maryland, United States

Meritus Center for Clinical Research; 🇺🇸 Hagerstown, Maryland, United States

MMCORC - Metro Minnesota; 🇺🇸 Saint Louis Park, Minnesota, United States

First Health of the Carolinas Cancer Center; 🇺🇸 Pinehurst, North Carolina, United States

Columbus; 🇺🇸 Columbus, Ohio, United States

UPMC Hillman Cancer Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

WellSpan Health/York Cancer Center; 🇺🇸 York, Pennsylvania, United States

Ballad Health Cancer Care-Kingsport; 🇺🇸 Kingsport, Tennessee, United States

Marshfield Medical Center Weston; 🇺🇸 Weston, Wisconsin, United States

Sanford NCORP of the North Central Plains; 🇺🇸 Fargo, North Dakota, United States

Wake Forest Baptist Health; 🇺🇸 Winston-Salem, North Carolina, United States

Kaiser Permanente Northwest; 🇺🇸 Portland, Oregon, United States

Reading Hospital; 🇺🇸 West Reading, Pennsylvania, United States