Liquid Biopsy in Early Colorectal Lesions
Starting soon
Conditions studied: Colorectal Neoplasms, Precancerous Conditions, Adenocarcinoma of the Colon
In brief
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.
Key facts
- Study ID
- NCT07319104
- Run by
- University Hospital, Montpellier
- People needed
- 1000
- Starts
- 2026-06-15
- Expected to finish
- 2031-12-15
- Last updated by the study team
- 2026-06-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- 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
Full record on ClinicalTrials.gov
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