Clinical trial NCT05210283: CORRECT Study of Minimal Residual Disease Detection in Colorectal Cancer
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Colorectal Cancer
Keywords: Colorectal
ctDNA
Lead sponsor: Exact Sciences Corporation
Sponsor class: INDUSTRY
Collaborators: name: NSABP Foundation Inc
First posted: 2022-01-27
Enrollment: 1016
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients over the age of 18 who have undergone surgery for stage II or III colorectal cancer

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.


Eligibility criteria: 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.

Primary outcomes:
measure: To validate the association of circulating tumor DNA (ctDNA) with recurrence-free interval (RFI).
timeFrame: 7 years
Secondary outcomes:
measure: To assess the sensitivity and specificity of ctDNA positivity for subsequent clinical recurrence.
timeFrame: 7 years
measure: To assess the contribution of ctDNA on RFI, independent of clinicopathological risk features and other biomarkers
timeFrame: 7 years
measure: To assess time from positive ctDNA to clinical recurrence
timeFrame: 7 years
Other outcomes:
Locations:
city: Mission Hills
country: United States
facility: Facey Medical Group - Mission Hills - Endoscopy Center & Gastroenterology
state: California
city: Torrance
country: United States
facility: Torrance Memorial Hunt Cancer Institute
state: California
city: Gainesville
country: United States
facility: University of Florida Division of Hematology & Oncology
state: Florida
city: Miami Beach
country: United States
facility: Mount Sinai Medical - Comprehensive Cancer Center
state: Florida
city: Orange City
country: United States
facility: Mid Florida Cancer Centers
state: Florida
city: Elmhurst
country: United States
facility: Edward Cancer Center
state: Illinois
city: Peoria
country: United States
facility: Illinois Cancer Care
state: Illinois
city: Cedar Rapids
country: United States
facility: Mercy Medical Center
state: Iowa
city: Westwood
country: United States
facility: University of Kansas Cancer Center
state: Kansas
city: Baltimore
country: United States
facility: MedStar Georgetown Cancer Institute at MedStar Georgetown University Hospital
state: Maryland
city: Hagerstown
country: United States
facility: Meritus Center for Clinical Research
state: Maryland
city: Towson
country: United States
facility: University of Maryland St. Joseph Medical Center
state: Maryland
city: St Louis Park
country: United States
facility: Metro Minnesota Community Oncology Consortium (MMCORC)
state: Minnesota
city: St. Louis
country: United States
facility: Missouri Baptist Medical Center
state: Missouri
city: Charlotte
country: United States
facility: Atrium Health Levine Cancer Institute
state: North Carolina
city: Pinehurst
country: United States
facility: FirstHealth Outpatient Cancer Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Atrium Health Wake Forest Baptist Medical Center
state: North Carolina
city: Fargo
country: United States
facility: Sanford Roger Maris Cancer Center
state: North Dakota
city: Columbus
country: United States
facility: Columbus NCORP
state: Ohio
city: Portland
country: United States
facility: Interstate Medical Office Central
state: Oregon
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Center
state: Pennsylvania
city: West Reading
country: United States
facility: Reading Hospital Hematology Oncology
state: Pennsylvania
city: Wynnewood
country: United States
facility: Lankenau Medical Center
state: Pennsylvania
city: York
country: United States
facility: WellSpan York Cancer Center
state: Pennsylvania
city: Greenville
country: United States
facility: Primsa Health Cancer Institute
state: South Carolina
city: Sioux Falls
country: United States
facility: Sanford Cancer Center
state: South Dakota
city: Kingsport
country: United States
facility: Ballad Health Cancer Center
state: Tennessee
city: Weston
country: United States
facility: Marshfield Medical Center Weston
state: Wisconsin
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Toronto
country: Canada
facility: Princess Margaret Cancer Center
state: Ontario
city: Montréal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Montréal
country: Canada
facility: McGill University Health - Glen Site
state: Quebec
Study officials:
References: