Monitoring tumor DNA methylation after surgery for colorectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Fudan University Shanghai Cancer Center
  Shanghai, Shanghai Municipality, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.