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NOT YET RECRUITING
NCT07319104

Liquid Biopsy in Early Colorectal Lesions

Sponsor: University Hospital, Montpellier

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

1000

Start Date

2026-03-01

Completion Date

2031-09-01

Last Updated

2026-01-22

Healthy Volunteers

No

Interventions

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.

Locations (12)

University Hospital of Amiens

Amiens, France

University Hospital of Bordeaux

Bordeaux, France

University Hospital of Brest

Brest, France

University Hospital of Dijon

Dijon, France

University Hospital of Limoges

Limoges, France

Civil Hospices of Lyon

Lyon, France

Jean Mermoy Private Hospital

Lyon, France

University Hospital of Montpellier

Montpellier, France

University Hospital of Nancy

Nancy, France

University Hospital of Nîmes

Nîmes, France

Saint Joseph Hospital

Paris, France

University Hospital of Rennes

Rennes, France