CORRECT Study of Minimal Residual Disease Detection in Colorectal Cancer

Description

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.

Conditions

Colorectal Cancer

Study Overview

Study Details

Study overview

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.

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

CORRECT Study of Minimal Residual Disease Detection in Colorectal Cancer

Condition
Colorectal Cancer
Intervention / Treatment

-

Contacts and Locations

Mission Hills

Providence Facey Medical Foundation, Mission Hills, California, United States, 91345

Torrance

Torrance Memorial Medical Center, Torrance, California, United States, 90505

Gainesville

University of Florida, Gainesville, Florida, United States, 32610

Miami Beach

Mount Sinai Medical - Comprehensive Cancer Center, Miami Beach, Florida, United States, 33140

Orange City

Mid Florida Hematology and Oncology Center, Orange City, Florida, United States, 32763

Elmhurst

Edwards Cancer Center, Elmhurst, Illinois, United States, 60126

Peoria

Illinois Cancer Care, Peoria, Illinois, United States, 61615

Cedar Rapids

Mercy Medical Center, Cedar Rapids, Iowa, United States, 52403

Baltimore

Medstar Franklin Square, Baltimore, Maryland, United States, 21237

Baltimore

Medstar Good Samaritan, Baltimore, Maryland, United States, 21239

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.
  • 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Exact Sciences Corporation,

Study Record Dates

2028-02-15