Colorectal Neoplasms, Precancerous Conditions, Adenocarcinoma of the Colon, Lymphatic Metastasis, Endoscopy, Gastrointestinal, Liquid Biopsy, Biomarkers
Conditions
Brief 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.
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.
Interventions
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
University Hospital, Montpellier
University Hospital, Limoges
Société Nationale Française de Gastroentérologie
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Extracellular vesicles (EVs) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Circulating nucleosomes | 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. |
| Circulating tumor DNA (ctDNA) | 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. |
| Circulating proteomic profile via O-link technology | 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. |
Countries
France
Contacts
CONTACTAntoine DEBOURDEAU, MD
CONTACTCatherine PANABIERES, MD, PhD
STUDY_CHAIRAntoine DEBOURDEAU, MD
University Hospital, Montpellier
Outcome results
None listed