Liquid Biopsy in Early Colorectal Lesions (FECCO-BioBank)

May 29, 2026 updated by: University Hospital, Montpellier

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Eligible patients will be identified and recruited in gastroenterology consultations, within the investigating centers to which they will be referred as part of routine care.

Description

Inclusion Criteria:

  • Patient of legal age (≥ 18 years)
  • Patient with a superficial colonic tumor refered for submucosal dissection
  • Patient included in the FECCo cohort (patients will be included concomitantly in FECCO-Biobank)
  • Patient wishing to participate in the FECCO-BioBank biological collection

Exclusion Criteria:

  • Person with significant comorbidities preventing blood sampling
  • Patients with a distant metastasis detected by imaging
  • Person unable to read and write French
  • Person who have expressed their opposition to participating in this research after being informed by an investigator and having read the information sheet
  • Person not benefiting from a national health insurance scheme
  • Person under legal protection, guardianship or curatorship
  • Person participating in other study with an ongoing exclusion period

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Extracellular vesicles (EVs)
Time Frame: 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.
Morning of endoscopic resection (Day 0), 2 and 6 weeks after Day 0 (only for pT1 tumor)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Circulating nucleosomes
Time Frame: Morning of endoscopic resection (Day 0), 2 and 6 weeks after Day 0 (only for pT1 tumor)

Detection of circulating nucleosomes:

  • 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.
Morning of endoscopic resection (Day 0), 2 and 6 weeks after Day 0 (only for pT1 tumor)
Circulating tumor DNA (ctDNA)
Time Frame: Morning of endoscopic resection (Day 0), 2 and 6 weeks after Day 0 (only for pT1 tumor)

Detection of ctDNA:

  • 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.
Morning of endoscopic resection (Day 0), 2 and 6 weeks after Day 0 (only for pT1 tumor)
Circulating proteomic profile via O-link technology
Time Frame: Morning of endoscopic resection (Day 0), 2 and 6 weeks after Day 0 (only for pT1 tumor)

Detection of circulating proteomic profile via O-link technology:

  • 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.
Morning of endoscopic resection (Day 0), 2 and 6 weeks after Day 0 (only for pT1 tumor)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Collaborators

University Hospital, Limoges
Société Nationale Française de Gastroentérologie

Investigators

  • Study Chair: Antoine DEBOURDEAU, MD, University Hospital, Montpellier

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 15, 2026

Primary Completion (Estimated)

March 15, 2029

Study Completion (Estimated)

December 15, 2031

Study Registration Dates

First Submitted

December 2, 2025

First Submitted That Met QC Criteria

December 19, 2025

First Posted (Actual)

January 6, 2026

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

May 29, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECHMPL25_0092
  • 2025-A02328-41 (Registry Identifier: ID-RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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