ACTIVE_NOT_RECRUITING

CORRECT Study of Minimal Residual Disease Detection in Colorectal Cancer

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2021-12-15
Study Completion:2027-02-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05210283

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Not specified
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Diagnosis of carcinoma of the colon or rectum (patients with lymphomatous, sarcomatous, or neuroendocrine features are not eligible).
  2. 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:
  3. 1. in the opinion of the surgeon, all grossly visible tumor was completely resected ("curative resection") and
  4. 2. histologic evaluation by the pathologist confirms the margins of the resected specimens are not involved by malignant cells.
  5. 3. Pathologic stage II or III
  6. 4. ECOG performance status ≤ 2 (0, 1 or 2).
  7. 5. Able to understand and provide informed consent.
  8. 6. Willing and able to comply with the study requirements, which includes the collection of approximately 43mL of blood for each research blood draw.
  1. 1. Initiated adjuvant therapy for current CRC diagnosis (note: prior neoadjuvant therapy acceptable).
  2. 2. Pregnant or breastfeeding at time of enrollment.
  3. 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. 4. Prior transplant history:
  5. 1. Prior allogeneic hematopoietic stem cell transplant at any time.
  6. 2. Prior solid organ transplant within the last 2 years prior to enrollment.
  7. 5. Multiple cancer diagnoses: Synchronous or asynchronous diagnoses (or suspicion) of multiple primary cancers at the time of eligibility screening.

Contacts and Locations

Study Locations (Sites)

Facey Medical Group - Mission Hills - Endoscopy Center & Gastroenterology
Mission Hills, California, 91345
United States
Torrance Memorial Hunt Cancer Institute
Torrance, California, 90505
United States
University of Florida Division of Hematology & Oncology
Gainesville, Florida, 32610
United States
Mount Sinai Medical - Comprehensive Cancer Center
Miami Beach, Florida, 33140
United States
Mid Florida Cancer Centers
Orange City, Florida, 32763
United States
Edward Cancer Center
Elmhurst, Illinois, 60126
United States
Illinois Cancer Care
Peoria, Illinois, 61615
United States
Mercy Medical Center
Cedar Rapids, Iowa, 52403
United States
University of Kansas Cancer Center
Westwood, Kansas, 66205
United States
MedStar Georgetown Cancer Institute at MedStar Georgetown University Hospital
Baltimore, Maryland, 21237
United States
Meritus Center for Clinical Research
Hagerstown, Maryland, 21742
United States
University of Maryland St. Joseph Medical Center
Towson, Maryland, 21093
United States
Metro Minnesota Community Oncology Consortium (MMCORC)
St Louis Park, Minnesota, 55426
United States
Missouri Baptist Medical Center
St. Louis, Missouri, 63131
United States
Atrium Health Levine Cancer Institute
Charlotte, North Carolina, 28204
United States
FirstHealth Outpatient Cancer Center
Pinehurst, North Carolina, 28374
United States
Atrium Health Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58104
United States
Columbus NCORP
Columbus, Ohio, 43215
United States
Interstate Medical Office Central
Portland, Oregon, 97227
United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
United States
Reading Hospital Hematology Oncology
West Reading, Pennsylvania, 19611
United States
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096
United States
WellSpan York Cancer Center
York, Pennsylvania, 17403
United States
Primsa Health Cancer Institute
Greenville, South Carolina, 29605
United States
Sanford Cancer Center
Sioux Falls, South Dakota, 57104
United States
Ballad Health Cancer Center
Kingsport, Tennessee, 37660
United States
Marshfield Medical Center Weston
Weston, Wisconsin, 54476
United States

Collaborators and Investigators

Sponsor: Exact Sciences Corporation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-12-15
Study Completion Date2027-02-15

Study Record Updates

Study Start Date2021-12-15
Study Completion Date2027-02-15

Terms related to this study

Keywords Provided by Researchers

  • Colorectal
  • ctDNA

Additional Relevant MeSH Terms

  • Colorectal Cancer