Actively Recruiting
Circulating Tumor DNA Methylation Guided Postoperative Follow-up Strategy for Non-metastatic Colorectal Cancer: a Multicenter, Prospective, Randomized Controlled Cohort Study (FIND Trial)
Led by Fudan University · Updated on 2025-09-18
584
Participants Needed
1
Research Sites
150 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Colorectal cancer (CRC) is a common and serious gastrointestinal tumor with high incidence and mortality rates worldwide. While early-stage CRC patients have a high survival rate, those with high-risk stage II and III CRC face lower survival and frequent recurrence after surgery. Researchers are evaluating the use of circulating tumor DNA (ctDNA) methylation detection as a more sensitive biomarker to predict and monitor postoperative recurrence and metastasis in non-metastatic CRC patients, aiming to improve follow-up strategies. The study compares two groups: one receiving dynamic ctDNA methylation monitoring alongside routine postoperative follow-up, and the other receiving only routine follow-up care. ctDNA testing is performed before surgery, shortly after surgery, and every three months for two years in the experimental group. If ctDNA testing indicates positive results after chemotherapy, additional imaging is conducted to detect recurrence or metastasis. Routine follow-up includes physical exams, blood tests for carcinoembryonic antigen (CEA), CT scans, and colonoscopies at scheduled intervals. Participants will undergo regular blood tests for ctDNA, physical exams, imaging scans, and questionnaires on quality of life and emotional distress for up to five years. Researchers will measure outcomes such as the rate of secondary curative treatment, time to cancer recurrence, disease-free survival, overall survival, and patient-reported outcomes. This study provides close monitoring and aims to identify recurrence earlier through ctDNA changes, potentially guiding more timely interventions.
CONDITIONS
Brief Title
Circulating Tumor DNA Methylation Guided Postoperative Follow-up Strategy for Non-metastatic Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any gender
- Performance status (PS) score over 80 or ECOG score between 0 and 2
- Preoperative imaging shows no distant metastasis and postoperative stage I to III colorectal cancer
- Radical surgery has been performed
- Expected survival longer than 12 months
- Signed informed consent indicating understanding and willingness to participate
You will not qualify if you...
- Blood transfusion during or within 2 weeks before surgery
- Incomplete baseline samples including preoperative plasma
- Missing two consecutive or three total plasma samples before positive ctDNA detection
- Pregnant or lactating women with fertility who do not use adequate contraception
- History of other malignant tumors within 5 years except certain cured cancers
- Uncontrolled primary brain tumor or central nervous system metastasis with symptoms
- Serious or unstable diseases such as recent heart conditions, neuropathy, psychosis, severe infections, bleeding disorders
- Significant impairment of major organ function
- Other conditions deemed unsuitable for trial participation by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 months
Participants undergo ctDNA methylation detection within one month before surgery and within one month after surgery to guide postoperative follow-up.
2 visits (in-person)
Duration - 2 years
Participants receive routine postoperative follow-up including physical examinations, CEA tests, imaging, and colonoscopy as appropriate. For those in the experimental group, ctDNA detection continues every three months for 2 years to monitor for recurrence and guide additional imaging if needed.
ctDNA detection every 3 months and physical examinations every 3 to 6 months during the first 2 years
Duration - Up to 5 years
Participants continue routine postoperative surveillance with less frequent physical exams, imaging annually, and colonoscopy as indicated up to 5 years after surgery.
Physical examinations and tests every 6 months to annually, annual imaging, and colonoscopy at years 1, 3, and every 5 years thereafter
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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