Liquid Biopsy in Early Colorectal Lesions

NCT07319104 | Not Yet Recruiting

• 2 other identifiers: RECHMPL25_00922025-A02328-41
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 12

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.

Conditions

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

Outcome Measures

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.

  Morning of endoscopic resection (Day 0), 2 and 6 weeks after Day 0 (only for pT1 tumor)

Secondary Outcomes (3)

• Circulating nucleosomes

  Morning of endoscopic resection (Day 0), 2 and 6 weeks after Day 0 (only for pT1 tumor)

• Circulating tumor DNA (ctDNA)

  Morning of endoscopic resection (Day 0), 2 and 6 weeks after Day 0 (only for pT1 tumor)

• Circulating proteomic profile via O-link technology

  Morning of endoscopic resection (Day 0), 2 and 6 weeks after Day 0 (only for pT1 tumor)

Interventions

Venous blood sampling OTHER

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.

Also known as: Blood sample

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

• 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

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

Sponsors & Collaborators

• University Hospital, Limoges: collaborator
• University Hospital, Montpellier: lead
• Société Nationale Française de Gastroentérologie: collaborator

Study Sites (12)

University Hospital of Amiens

Amiens, 80054, France

Location

University Hospital of Bordeaux

Bordeaux, 33604, France

Location

University Hospital of Brest

Brest, 29200, France

Location

University Hospital of Dijon

Dijon, 21079, France

Location

University Hospital of Limoges

Limoges, 87042, France

Location

Civil Hospices of Lyon

Lyon, 69003, France

Location

Jean Mermoy Private Hospital

Lyon, 69008, France

Location

University Hospital of Montpellier

Montpellier, 34095, France

Location

University Hospital of Nancy

Nancy, 54511, France

Location

University Hospital of Nîmes

Nîmes, 30029, France

Location

Saint Joseph Hospital

Paris, 75014, France

Location

University Hospital of Rennes

Rennes, 35033, France

Location

Related Publications (7)

• Lecomte 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 BACKGROUND

• Zwager 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 BACKGROUND

• Alix-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 BACKGROUND

• Chung 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 BACKGROUND

• Wada 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.

  PMID: 33819484 BACKGROUND

• Miyazaki K, Wada Y, Okuno K, Murano T, Morine Y, Ikemoto T, Saito Y, Ikematsu H, Kinugasa Y, Shimada M, Goel A. An exosome-based liquid biopsy signature for pre-operative identification of lymph node metastasis in patients with pathological high-risk T1 colorectal cancer. Mol Cancer. 2023 Jan 6;22(1):2. doi: 10.1186/s12943-022-01685-8.

  PMID: 36609320 BACKGROUND

• Schlemper RJ, Riddell RH, Kato Y, Borchard F, Cooper HS, Dawsey SM, Dixon MF, Fenoglio-Preiser CM, Flejou JF, Geboes K, Hattori T, Hirota T, Itabashi M, Iwafuchi M, Iwashita A, Kim YI, Kirchner T, Klimpfinger M, Koike M, Lauwers GY, Lewin KJ, Oberhuber G, Offner F, Price AB, Rubio CA, Shimizu M, Shimoda T, Sipponen P, Solcia E, Stolte M, Watanabe H, Yamabe H. The Vienna classification of gastrointestinal epithelial neoplasia. Gut. 2000 Aug;47(2):251-5. doi: 10.1136/gut.47.2.251.

  PMID: 10896917 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be taken before and after submucosal dissections, processed, and then stored as plasma. Further in-depth analyses can then be performed, including analyses of circulating tumor DNA, broad protein panels, exosomes, extracellular vesicles, and immune system cells, etc.

MeSH Terms

Conditions

Colorectal Neoplasms; Precancerous Conditions; Colonic Neoplasms; Lymphatic Metastasis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Antoine DEBOURDEAU, MD

  University Hospital, Montpellier

  STUDY CHAIR

Central Study Contacts

Antoine DEBOURDEAU, MD

CONTACT

+334.67.33.07.83; a-debourdeau@chu-montpellier.fr

Catherine PANABIERES, MD, PhD

CONTACT

c-panabieres@chu-montpellier.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: January 6, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): September 1, 2031
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (12)