CORRECT Study of Minimal Residual Disease Detection in Colorectal Cancer

Colorectal Cancer Clinical Trial

— MRD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05210283
• Other study ID #: 16-002
• Status: Recruiting
• Start date: December 15, 2021
• Est. completion date: February 15, 2028

Study information

• Verified date: February 2023
• Source: Exact Sciences Corporation
• Contact: NSABP Department of Site and Study Management Department of Site
• Phone: 1-800-270-3165
• Email: industry.trials[@]nsabp.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 750
• Est. completion date: February 15, 2028
• Est. primary completion date: February 15, 2028
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Neoplasm, Residual

Intervention

Device:
• MRD
ctDNA MRD test

Locations

Country	Name	City	State
Canada	McGill University Health Centre-Cedars Cancer Centre	Montreal	Quebec
United States	Medstar Franklin Square	Baltimore	Maryland
United States	Medstar Good Samaritan	Baltimore	Maryland
United States	Mercy Medical Center	Cedar Rapids	Iowa
United States	Levine Cancer Institute	Charlotte	North Carolina
United States	Columbus	Columbus	Ohio
United States	Edwards Cancer Center	Elmhurst	Illinois
United States	Sanford NCORP of the North Central Plains	Fargo	North Dakota
United States	University of Florida	Gainesville	Florida
United States	Primsa health Cancer Institute - Butternut	Greenville	South Carolina
United States	Meritus Center for Clinical Research	Hagerstown	Maryland
United States	Ballad Health Cancer Care-Kingsport	Kingsport	Tennessee
United States	Mount Sinai Medical - Comprehensive Cancer Center	Miami Beach	Florida
United States	Providence Facey Medical Foundation	Mission Hills	California
United States	Mid Florida Hematology and Oncology Center	Orange City	Florida
United States	Illinois Cancer Care	Peoria	Illinois
United States	First Health of the Carolinas Cancer Center	Pinehurst	North Carolina
United States	UPMC Hillman Cancer Center	Pittsburgh	Pennsylvania
United States	Kaiser Permanente Northwest	Portland	Oregon
United States	Missouri Baptist Medical Center	Saint Louis	Missouri
United States	MMCORC - Metro Minnesota	Saint Louis Park	Minnesota
United States	Sanford Cancer Center Oncology Clinic	Sioux Falls	South Dakota
United States	Torrance Memorial Medical Center	Torrance	California
United States	University of Maryland St. Joseph Medical Center	Towson	Maryland
United States	Reading Hospital	West Reading	Pennsylvania
United States	Marshfield Medical Center Weston	Weston	Wisconsin
United States	Wake Forest Baptist Health	Winston-Salem	North Carolina
United States	Lankenau Medical Center	Wynnewood	Pennsylvania
United States	WellSpan Health/York Cancer Center	York	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Exact Sciences Corporation	NSABP Foundation Inc

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To validate the association of circulating tumor DNA (ctDNA) with recurrence-free interval (RFI).		7 years
Secondary	To assess the sensitivity and specificity of ctDNA positivity for subsequent clinical recurrence.		7 years
Secondary	To assess the contribution of ctDNA on RFI, independent of clinicopathological risk features and other biomarkers		7 years
Secondary	To assess time from positive ctDNA to clinical recurrence		7 years