Liquid Biopsy in Early Colorectal Lesions

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.

NCT Number	NCT07319104
Lead Sponsor	University Hospital, Montpellier Collaborators: University Hospital, Limoges, Société Nationale Française de Gastroentérologie
Conditions	Colorectal Neoplasms, Precancerous Conditions, Adenocarcinoma of the Colon
Enrollment	1,000 participants
Start Date	2026-06-15
Primary Completion	2029-03-15 (estimated)
Study Completion	2031-12-15 (estimated)
Updated on ClinicalTrials.gov	2026-06-02