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Studies

Observational Not yet recruiting

NCT07319104 on ClinicalTrials.gov

Liquid Biopsy in Early Colorectal Lesions

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

  • Sponsor: Hôpital Lapeyronie
  • Collaborators: University Hospital, Limoges, Société Nationale Française de Gastroentérologie
  • Enrollment: 1000 (Estimated)
  • Study start: 2026-06-15 (Estimated)
  • Primary completion: 2029-03-15 (Estimated)
  • Study completion: 2031-12-15 (Estimated)
  • Allocation: N/a
  • InterventionModel: N/a
  • Masking: None
  • PrimaryPurpose: Other

Brief 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.

Conditions

  • Colorectal Neoplasms
  • Precancerous Conditions
  • Adenocarcinoma of the Colon

Intervention / Treatment

  • Other: Venous blood sampling

Primary Outcome Measures

  • Extracellular vesicles (EVs) (Morning of endoscopic resection (Day 0), 2 and 6 weeks after Day 0 (only for pT1 tumor))
    Detection of plasma extracellular vesicles (EVs): * to predict the presence of adenocarcinomatous degeneration (malignant profile) vs. dysplasia (benign profile) * to differentiate patients with pT1 adenocarcinoma of the colon, with lymph node metastasis (N+), from those without lymph node metastasis (N-) before treatment.

Countries

France

Locations and Investigators

  • University Hospital of Amiens, Amiens, France
  • University Hospital of Bordeaux, Bordeaux, France
    • Arthur BERGER, MD
  • University Hospital of Brest, Brest, France
    • Lucille QUENEHERVE, MD
  • University Hospital of Dijon, Dijon, France
    • Thibault DEGAND, MD
  • University Hospital of Limoges, Limoges, France
    • Jeremy JACQUES, MD, PhD
  • Civil Hospices of Lyon, Lyon, France
    • Mathieu PIOCHE, MD, PhD
  • Jean Mermoy Private Hospital, Lyon, France
    • Sarah LEBLANC, MD
  • University Hospital of Montpellier, Montpellier, France
    • Antoine DEBOURDEAU, MD
  • University Hospital of Nancy, Nancy, France
    • SCHAEFFER Marion, MD
  • University Hospital of Nîmes, Nîmes, France
    • Ludovic CAILLO, MD
  • Saint Joseph Hospital, Paris, France
    • Yann LE BALEUR, MD
  • University Hospital of Rennes, Rennes, France
    • Timothée WALLENHORST, MD

Study Officials

  • Antoine DEBOURDEAU, MD (Study Chair) — University Hospital, Montpellier