NCT07319104

Liquid Biopsy in Early Colorectal Lesions

Biobank for Validating Liquid Biopsy in Predicting the Prognosis of Superficial Colonic Lesions

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Introduction : Early colorectal cancer screening increasingly identifies superficial colonic lesions, but current diagnostic tools often fail to accurately distinguish benign from malignant lesions or to predict lymph node involvement. As histological criteria have limited predictive value, many patients with T1 tumors undergo unnecessary surgery. Liquid biopsy, based on circulating blood biomarkers, offers a promising non-invasive alternative that may improve diagnostic precision. Aim : The study aims to build a biobank of 1,000 patients with superficial colonic tumors to identify and validate circulating biomarker signatures capable of predicting tumor malignancy and lymph node status. The hypothesis is that liquid biopsy markers can reliably differentiate benign from malignant lesions and identify patients at risk of lymph node metastasis. Methods : This is a multicenter prospective cohort study embedded in the FECCo cohort. Blood samples will be collected at the time of endoscopic resection and, for pT1 lesions, again 2-6 weeks later. Clinical data will be retrieved annually from the FECCo database. Diagnostic performance of circulating biomarkers will be assessed using ROC curves, logistic regression (Lasso), and bootstrap validation to identify signatures associated with malignancy and lymph node involvement.

Conditions

• Colorectal Neoplasms
• Precancerous Conditions
• Adenocarcinoma of the Colon
• Lymphatic Metastasis
• Endoscopy, Gastrointestinal
• Liquid Biopsy
• Biomarkers

Interventions

Type	Name	Description
OTHER	Venous blood sampling	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.

Timeline

• Start date: 2026-03-01
• Primary completion: 2028-12-01
• Completion: 2031-09-01
• First posted: 2026-01-06
• Last updated: 2026-01-22

Locations

12 sites across 1 country: France