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Detecting minimal residual disease in colorectal cancer patients after surgery

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

Observational Exact Sciences Corporation · NCT05210283

This study is testing if checking for tiny amounts of cancer DNA in the blood can help doctors spot if colorectal cancer comes back after surgery in patients who have had stage II or III cancer.

Quick facts

Study typeObservational
Enrollment750 (estimated)
Ages18 Years and up
SexAll
SponsorExact Sciences Corporation Industry-sponsored
Drugs / interventionsradiation
Locations29 sites (Mission Hills, California and 28 other locations)
Trial IDNCT05210283 on ClinicalTrials.gov

What this trial studies

The CORRECT study aims to enroll patients who have had complete surgical resection for stage II or III colorectal cancer to monitor for recurrence over a period of 3 to 5 years. This observational study will focus on the detection of minimal residual disease (MRD) using circulating tumor DNA (ctDNA) as a biomarker. By following these patients, the study seeks to understand the relationship between MRD detection and cancer recurrence, potentially improving post-surgical monitoring strategies.

Who should consider this trial

Good fit: Ideal candidates are patients who have undergone complete surgical resection for stage II or III colorectal cancer within the last 180 days.

Not a fit: Patients with lymphomatous, sarcomatous, or neuroendocrine features, or those who have not had a curative resection, will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance early detection of colorectal cancer recurrence, leading to timely interventions.

How similar studies have performed: Other studies have shown promise in using ctDNA for monitoring minimal residual disease, indicating a growing interest in this approach.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Mission Hills, California and 28 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Colorectal CancerColorectalctDNA
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.