Liquid Biopsy in Early Colorectal Lesions (NCT07319104) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Liquid Biopsy in Early Colorectal Lesions
France1,000 participantsStarted 2026-06-15
Plain-language summary
Early colorectal cancer screening increasingly detects small superficial colonic lesions, but current diagnostic tools still struggle to distinguish benign from malignant lesions and to assess lymph node risk. As histology after resection has limited accuracy, many patients undergo unnecessary surgery.
Liquid biopsy, analyzing circulating biomarkers such as tumor DNA, extracellular vesicles, and nucleosomes, offers a non-invasive way to better classify these lesions. Emerging evidence suggests it may outperform current criteria for predicting lymph node involvement in T1 colorectal cancer.
This study will establish a biobank of 1,000 patients to identify blood-based signatures that predict tumor stage and lymph node status. The hypothesis of the study is that circulating biomarkers can accurately differentiate benign from malignant lesions and identify patients with or without lymph node metastasis.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient of legal age (≥ 18 years)
* Patient with a superficial colonic tumor refered for submucosal dissection
* Patient included in the FECCo cohort (patients will be included concomitantly in FECCO-Biobank)
* Patient wishing to participate in the FECCO-BioBank biological collection
Exclusion Criteria:
* Person with significant comorbidities preventing blood sampling
* Patients with a distant metastasis detected by imaging
* Person unable to read and write French
* Person who have expressed their opposition to participating in this research after being informed by an investigator and having read the information sheet
* Person not benefiting from a national health insurance scheme
* Person under legal protection, guardianship or curatorship
* Person participating in other study with an ongoing exclusion period
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Extracellular vesicles (EVs)
Timeframe: Morning of endoscopic resection (Day 0), 2 and 6 weeks after Day 0 (only for pT1 tumor)