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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-A02328-41 | Registry Identifier | ID-RCB |
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| Name | Class |
|---|---|
| University Hospital, Limoges | OTHER |
| Société Nationale Française de Gastroentérologie | OTHER |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Venous blood sampling | Other | Five 6-7 ml EDTA tubes of venous blood will be collected at two points during the care pathway:
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|
| Measure | Description | Time Frame |
|---|---|---|
| Extracellular vesicles (EVs) | Detection of plasma extracellular vesicles (EVs):
| Morning of endoscopic resection (Day 0), 2 and 6 weeks after Day 0 (only for pT1 tumor) |
| Measure | Description | Time Frame |
|---|---|---|
| Circulating nucleosomes | Detection of circulating nucleosomes:
| Morning of endoscopic resection (Day 0), 2 and 6 weeks after Day 0 (only for pT1 tumor) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antoine DEBOURDEAU, MD | Contact | +334.67.33.07.83 | a-debourdeau@chu-montpellier.fr | |
| Catherine PANABIERES, MD, PhD | Contact | c-panabieres@chu-montpellier.fr |
| Name | Affiliation | Role |
|---|---|---|
| Antoine DEBOURDEAU, MD | University Hospital, Montpellier | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Amiens | Amiens | 80054 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38383162 | Background | 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. | |
| 35436498 |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D011230 | Precancerous Conditions |
| D003110 | Colonic Neoplasms |
| D008207 | Lymphatic Metastasis |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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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.
| Circulating tumor DNA (ctDNA) | Detection of 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 | Detection of circulating proteomic profile via O-link technology:
| Morning of endoscopic resection (Day 0), 2 and 6 weeks after Day 0 (only for pT1 tumor) |
| University Hospital of Bordeaux | Bordeaux | 33604 | France |
|
| University Hospital of Brest | Brest | 29200 | France |
|
| University Hospital of Dijon | Dijon | 21079 | France |
|
| University Hospital of Limoges | Limoges | 87042 | France |
|
| Civil Hospices of Lyon | Lyon | 69003 | France |
|
| Jean Mermoy Private Hospital | Lyon | 69008 | France |
|
| University Hospital of Montpellier | Montpellier | 34095 | France |
|
| University Hospital of Nancy | Nancy | 54511 | France |
|
| University Hospital of Nîmes | Nîmes | 30029 | France |
|
| Saint Joseph Hospital | Paris | 75014 | France |
|
| University Hospital of Rennes | Rennes | 35033 | France |
|
| 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. |
| 33811121 | 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. |
| 38477985 | 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. |
| 33819484 | 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. |
| 36609320 | 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. |
| 10896917 | 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. |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D009362 | Neoplasm Metastasis |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |