Monitoring tumor DNA methylation after surgery for colorectal cancer
Circulating Tumor DNA Methylation Guided Postoperative Follow-up Strategy for Non-metastatic Colorectal Cancer: a Multicenter, Prospective, Randomized Controlled Cohort Study (FIND Trial)
NA · Fudan University · NCT05904665
This study is testing if checking for tumor DNA in the blood after surgery can help doctors better monitor recovery and spot any signs of colorectal cancer coming back in patients who are at high risk.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 584 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Fudan University (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT05904665 on ClinicalTrials.gov |
What this trial studies
This study focuses on patients with non-metastatic colorectal cancer who have undergone radical surgery. It aims to utilize circulating tumor DNA (ctDNA) methylation as a method for dynamic monitoring of postoperative outcomes. By analyzing ctDNA in the blood, the study seeks to predict the efficacy of treatment and monitor for potential recurrence. The approach is designed to improve follow-up strategies for high-risk patients, enhancing their chances of early detection of any issues.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with stage I to III colorectal cancer who have undergone radical surgery and have an expected survival of more than 12 months.
Not a fit: Patients who have undergone blood transfusions around the time of surgery or those with incomplete baseline samples may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective postoperative monitoring and improved survival rates for colorectal cancer patients.
How similar studies have performed: Previous studies have shown promise in using ctDNA methylation for monitoring cancer, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥ 18 years old, regardless of gender; 2. Personal status (PS) score as over 80 or Eastern Cooperative Oncology Group (ECOG) score as 0 \~ 2; 3. Preoperative imaging examinations reveal no definite distant metastatic lesions, and postoperative pTNM staging confirms patients with stage I to III colorectal cancer; 4. Radical operation performed ; 5. With expected survival of more than 12 months; 6. The subjects (or their legal representative / Guardian) must sign the informed consent form, indicating that they understand the purpose of the study, understand the necessary procedures of the study, and are willing to participate in the study. Exclusion Criteria: 1. Blood transfusion performed during operation or within 2 weeks before operation; 2. Incomplete baseline samples, including preoperative plasma samples; 3. Two consecutive test points missing or three plasma samples missing in total before a positive ctDNA time point; 4. Pregnant or lactating women who have fertility and do not take adequate contraceptive measures; 5. Have a history of other malignant tumors within 5 years, except cured cervical carcinoma in situ or non melanoma skin cancer; 6. Primary brain tumor or central nerve metastasis is not under control, with obvious intracranial hypertension or neuropsychiatric symptoms; 7. Patients with the following serious or uncontrollable diseases: severe heart disease, the condition is still unstable after treatment, including myocardial infarction, congestive heart failure, unstable angina pectoris, pericardial effusion with obvious symptoms or unstable arrhythmia within 6 months before enrollment; definite neuropathy or psychosis, including dementia or seizures; severe or uncontrolled infection; active disseminated intravascular coagulation and obvious bleeding tendency; 8. Significant impairment of important organ function; 9. Other conditions in which the investigator believes that the patient should not participate in this trial.
Where this trial is running
Shanghai, Shanghai Municipality
- Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (RECRUITING)
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.
Conditions: Non-metastatic Colorectal Cancer, Circulating Tumor DNA Methylation