Liquid Biopsy in Early Colorectal Lesions

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-03-01

Study Completion Date

2031-09-01

Brief Summary

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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.

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Detailed Description

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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

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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Blood sample

Eligibility Criteria

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Inclusion Criteria

* Patient of legal age (≥ 18 years)
* Patient with a superficial colonic tumor treated by submucosal dissection
* Patient included in the FECCo cohort
* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No