Clinical trial · Observational
Liquid Biopsy in Early Colorectal Lesions
Biobank for Validating Liquid Biopsy in Predicting the Prognosis of Superficial Colonic Lesions
NCT07319104CI-TRIAL-00113285FECCO-BioBanknot yet recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma of the Colon | Colon Adenocarcinoma | ALIAS | 0.90 |
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Precancerous Conditions | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Venous blood sampling | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Extracellular vesicles (EVs)
- timeFrame
- Morning of endoscopic resection (Day 0), 2 and 6 weeks after Day 0 (only for pT1 tumor)
- description
- 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 outcomes (3)
- measure
- Circulating nucleosomes
- timeFrame
- Morning of endoscopic resection (Day 0), 2 and 6 weeks after Day 0 (only for pT1 tumor)
- description
- 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.
- measure
- Circulating tumor DNA (ctDNA)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (7)
- BACKGROUNDLecomte T, Tougeron D, Chautard R, Bressand D, Bibeau F, Blanc B, Cohen R, Jacques J, Lagasse JP, Laurent-Puig P, Lepage C, Lucidarme O, Martin-Babau J, Panis Y, Portales F, Taieb J, Aparicio T, Bouche O; Thesaurus National de Cancerologie Digestive (TNCD); Societe Nationale Francaise de Gastroenterologie (SNFGE); Federation Francophone de Cancerologie Digestive (FFCD); Groupe Cooperateur multidisciplinaire en Oncologie (GERCOR); Federation Nationale des Centres de Lutte Contre le Cancer (UNICANCER); Societe Francaise de Chirurgie Digestive (SFCD); Societe Francaise d'Endoscopie Digestive (SFED); Societe Francaise de Radiotherapie Oncologique (SFRO); Association de Chirurgie Hepato-Bilio-Pancreatique et Transplantation (ACHBT); Societe Francaise de Pathologie (SFP); Association Francaise pour l'Etude du Foie (AFEF); Societe Francaise de Radiologie (SFR). Non-metastatic colon cancer: French Intergroup Clinical Practice Guidelines for diagnosis, treatments, and follow-up (TNCD, SNFGE, FFCD, GERCOR, UNICANCER, SFCD, SFED, SFRO, ACHBT, SFP, AFEF, and SFR). Dig Liver Dis. 2024 May;56(5):756-769. doi: 10.1016/j.dld.2024.01.208. Epub 2024 Feb 20. PMID 38383162
- BACKGROUNDZwager LW, Bastiaansen BAJ, Montazeri NSM, Hompes R, Barresi V, Ichimasa K, Kawachi H, Machado I, Masaki T, Sheng W, Tanaka S, Togashi K, Yasue C, Fockens P, Moons LMG, Dekker E. Deep Submucosal Invasion Is Not an Independent Risk Factor for Lymph Node Metastasis in T1 Colorectal Cancer: A Meta-Analysis. Gastroenterology. 2022 Jul;163(1):174-189. doi: 10.1053/j.gastro.2022.04.010. Epub 2022 Apr 15. PMID 35436498
- BACKGROUNDAlix-Panabieres C, Pantel K. Liquid Biopsy: From Discovery to Clinical Application. Cancer Discov. 2021 Apr;11(4):858-873. doi: 10.1158/2159-8290.CD-20-1311. PMID 33811121
- BACKGROUNDChung DC, Gray DM 2nd, Singh H, Issaka RB, Raymond VM, Eagle C, Hu S, Chudova DI, Talasaz A, Greenson JK, Sinicrope FA, Gupta S, Grady WM. A Cell-free DNA Blood-Based Test for Colorectal Cancer Screening. N Engl J Med. 2024 Mar 14;390(11):973-983. doi: 10.1056/NEJMoa2304714. PMID 38477985
- BACKGROUNDWada Y, Shimada M, Murano T, Takamaru H, Morine Y, Ikemoto T, Saito Y, Balaguer F, Bujanda L, Pellise M, Kato K, Saito Y, Ikematsu H, Goel A. A Liquid Biopsy Assay for Noninvasive Identification of Lymph Node Metastases in T1 Colorectal Cancer. Gastroenterology. 2021 Jul;161(1):151-162.e1. doi: 10.1053/j.gastro.2021.03.062. Epub 2021 Apr 2.