Detecting minimal residual disease in colorectal cancer after surgery
CORRECT-MRD I: First Colorectal Cancer Clinical Validation Study to Predict Recurrence Using a Circulating Tumor DNA Assay to Detect Minimal Residual Disease
This study is trying to see if tracking tiny amounts of cancer DNA in the blood can help doctors find out if colorectal cancer comes back after surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Exact Sciences Corporation Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 10 sites (Afula, North and 9 other locations) |
| Trial ID | NCT06398743 on ClinicalTrials.gov |
What this trial studies
The CORRECT - MRD I study aims to enroll patients who have had complete surgical resection for stage II or III colorectal cancer and will follow them for up to 5 years to monitor for recurrence. This observational study focuses on the detection of minimal residual disease (MRD) using circulating tumor DNA (ctDNA) as a biomarker. By tracking MRD, the study seeks to improve understanding of cancer recurrence and potentially guide future treatment decisions.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older 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 complete surgical resection, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier detection of cancer recurrence in colorectal cancer patients, allowing for timely interventions.
How similar studies have performed: Other studies have shown promise in using ctDNA for monitoring minimal residual disease, indicating a growing interest and potential in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
Subject is/has:
1. 18 years of age or older.
2. Diagnosis of carcinoma of the colon or rectum (patients with lymphomatous, sarcomatous,or neuroendocrine features are not eligible).
3. 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 form 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.
4. Pathologic Stage II or III CRC.
5. ECOG performance status ≤ 2 (0, 1 or 2).
6. Able to understand and provide written informed consent.
7. Willing and able to comply with the study requirements, which includes the collection of approximately 35mL of blood for each research blood draw.
Exclusion Criteria:
Subject is/has:
1. Initiated adjuvant therapy for current CRC diagnosis (note: neoadjuvant therapy acceptable).
2. Known pregnancy 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
Afula, North and 9 other locations
- HaEmek Medical Center — Afula, North, Israel (Recruiting)
- Hadassah Medical Center — Jerusalem, Israel (Recruiting)
- Istituto Clinico Humanitas — Rozzano, Milano, Italy (Recruiting)
- ASST Grande Ospedale Metropolitano Niguarda — Milano, Italy (Recruiting)
- Istituto Nazionale Tumori - Fondazione G Pascale — Napoli, Italy (Recruiting)
- Hospital Universitario La Paz — Madrid, Spain (Recruiting)
- Centro Integral Oncológico Clara Campal (HM CIOCC) — Madrid, Spain (Recruiting)
- Edinburgh Cancer Centre — Edinburgh, Scotland, United Kingdom (Recruiting)
- Ipswich Hospital — Ipswich, United Kingdom (Recruiting)
- Torbay Hospital — Torquay, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Melanie Palomares, MD
- Email: mpalomares@exactsciences.com
- Phone: 650-569-2482
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.