Liquid Biopsy in Early Colorectal Lesions

Sponsor
University Hospital, Montpellier
Study ID
NCT07319104
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Venous blood sampling — OTHER
    Five 6-7 ml EDTA tubes of venous blood will be collected at two points during the care pathway: * Immediately before the endoscopic procedure, at the time of catheter insertion for general anesthesia. This is to study the signal intensity at a baseline stage. * Between 2 and 6 weeks after submucosal dissection (only in cases of pT1 adenocarcinoma) and before any further surgery for pT1 cancer. This is to study the presence or absence of a residual signal after local resection.

Study Details

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.

Key Dates

First listed
Jan 6, 2026
Start date
Jun 15, 2026
Status verified
May 2026
Primary completion
Mar 15, 2029
Completion
Dec 15, 2031

Study Design

Enrollment
1,000 participants (estimated)

Primary Outcome Measure

Extracellular vesicles (EVs) [ Time Frame: Morning of endoscopic resection (Day 0), 2 and 6 weeks after Day 0 (only for pT1 tumor) ]

Central Contacts

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