Liquid Biopsy in Early Colorectal Lesions
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Montpellier
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Venous blood sampling
Other interventionFive 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Extracellular vesicles (EVs)
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.
Time frame
Morning of endoscopic resection (Day 0), 2 and 6 weeks after Day 0 (only for pT1 tumor)Secondary outcomes
1
Circulating nucleosomes
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.
Time frame
Morning of endoscopic resection (Day 0), 2 and 6 weeks after Day 0 (only for pT1 tumor)2
Circulating tumor DNA (ctDNA)
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.
Time frame
Morning of endoscopic resection (Day 0), 2 and 6 weeks after Day 0 (only for pT1 tumor)3
Circulating proteomic profile via O-link technology
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.
Time frame
Morning of endoscopic resection (Day 0), 2 and 6 weeks after Day 0 (only for pT1 tumor)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital, Montpellier
Lead sponsor
University Hospital, Limoges
Collaborator
Société Nationale Française de Gastroentérologie
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: