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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Stage ll or lll Patients with stage ll or lll colorectal cancer
  • Device: MRD
    ctDNA MRD test

Recruiting Locations

Medstar Franklin Square
Baltimore, Maryland 21237
Contact:
Kevin Chen

Medstar Good Samaritan
Baltimore, Maryland 21239
Contact:
Mahsa Mohebtash

More Details

Status
Recruiting
Sponsor
Exact Sciences Corporation

Study Contact

NSABP Department of Site and Study Management Department of Site and Study Management
1-800-270-3165
industry.trials@nsabp.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.