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Liquid Biopsy in Early Colorectal Lesions

NCT07319104 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2026-01-22

No results posted yet for this study

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
  • Lymphatic Metastasis
  • Endoscopy, Gastrointestinal
  • Liquid Biopsy
  • Biomarkers

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.

Sponsors & Collaborators

  • University Hospital, Limoges

    collaborator OTHER

  • Société Nationale Française de Gastroentérologie

    collaborator OTHER

  • University Hospital, Montpellier

    lead OTHER

Principal Investigators

  • Antoine DEBOURDEAU, MD · University Hospital, Montpellier

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2028-12-01
Completion
2031-09-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07319104 on ClinicalTrials.gov