Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-29 @ 11:53 PM
Study NCT ID:
NCT07319104
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-22
First Post:
2025-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Liquid Biopsy in Early Colorectal Lesions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D008207', 'term': 'Lymphatic Metastasis'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '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.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2031-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-19', 'studyFirstSubmitDate': '2025-12-02', 'studyFirstSubmitQcDate': '2025-12-19', 'lastUpdatePostDateStruct': {'date': '2026-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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):\n\n* to predict the presence of adenocarcinomatous degeneration (malignant profile) vs. dysplasia (benign profile)\n* to differentiate patients with pT1 adenocarcinoma of the colon, with lymph node metastasis (N+), from those without lymph node metastasis (N-) before treatment.'}], 'secondaryOutcomes': [{'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:\n\n* to predict the presence of adenocarcinomatous degeneration (malignant profile) vs. dysplasia (benign profile)\n* 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)', 'timeFrame': 'Morning of endoscopic resection (Day 0), 2 and 6 weeks after Day 0 (only for pT1 tumor)', 'description': 'Detection of ctDNA:\n\n* to predict the presence of adenocarcinomatous degeneration (malignant profile) vs. dysplasia (benign profile)\n* 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 proteomic profile via O-link technology', 'timeFrame': 'Morning of endoscopic resection (Day 0), 2 and 6 weeks after Day 0 (only for pT1 tumor)', 'description': 'Detection of circulating proteomic profile via O-link technology:\n\n* to predict the presence of adenocarcinomatous degeneration (malignant profile) vs. dysplasia (benign profile)\n* to differentiate patients with pT1 adenocarcinoma of the colon, with lymph node metastasis (N+), from those without lymph node metastasis (N-) before treatment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colorectal Neoplasms', 'Precancerous Conditions', 'Adenocarcinoma of the Colon', 'Lymphatic Metastasis', 'Endoscopy, Gastrointestinal', 'Liquid Biopsy', 'Biomarkers']}, 'referencesModule': {'references': [{'pmid': '38383162', 'type': 'BACKGROUND', 'citation': "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': '35436498', 'type': 'BACKGROUND', 'citation': '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': '33811121', 'type': 'BACKGROUND', 'citation': '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': '38477985', 'type': 'BACKGROUND', 'citation': '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': '33819484', 'type': 'BACKGROUND', 'citation': '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': '36609320', 'type': 'BACKGROUND', 'citation': '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': '10896917', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nLiquid 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.\n\nThis 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.', 'detailedDescription': 'Introduction :\n\nEarly 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.\n\nAim :\n\nThe 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.\n\nMethods :\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient of legal age (≥ 18 years)\n* Patient with a superficial colonic tumor treated by submucosal dissection\n* Patient included in the FECCo cohort\n* Patient wishing to participate in the FECCO-BioBank biological collection\n\nExclusion Criteria:\n\n* Person with significant comorbidities preventing blood sampling\n* Patients with a distant metastasis detected by imaging\n* Person unable to read and write French\n* Person who have expressed their opposition to participating in this research after being informed by an investigator and having read the information sheet\n* Person not benefiting from a national health insurance scheme\n* Person under legal protection, guardianship or curatorship\n* Person participating in other study with an ongoing exclusion period'}, 'identificationModule': {'nctId': 'NCT07319104', 'acronym': 'FECCO-BioBank', 'briefTitle': 'Liquid Biopsy in Early Colorectal Lesions', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Biobank for Validating Liquid Biopsy in Predicting the Prognosis of Superficial Colonic Lesions', 'orgStudyIdInfo': {'id': 'RECHMPL25_0092'}, 'secondaryIdInfos': [{'id': '2025-A02328-41', 'type': 'REGISTRY', 'domain': 'ID-RCB'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Venous blood sampling', 'type': 'OTHER', 'otherNames': ['Blood sample'], 'description': 'Five 6-7 ml EDTA tubes of venous blood will be collected at two points during the care pathway:\n\n* 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.\n* 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.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '80054', 'city': 'Amiens', 'country': 'France', 'contacts': [{'name': 'Clara YZET, MD', 'role': 'CONTACT', 'email': 'yzet.clara@chu-amiens.fr'}], 'facility': 'University Hospital of Amiens', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'zip': '33604', 'city': 'Bordeaux', 'country': 'France', 'contacts': [{'name': 'Arthur BERGER, MD', 'role': 'CONTACT', 'email': 'arthur.berger@chu-bordeaux.fr'}], 'facility': 'University Hospital of Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '29200', 'city': 'Brest', 'country': 'France', 'contacts': [{'name': 'Lucille QUENEHERVE, MD', 'role': 'CONTACT', 'email': 'lucille.queneherve@chu-brest.fr'}], 'facility': 'University Hospital of Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '21079', 'city': 'Dijon', 'country': 'France', 'contacts': [{'name': 'Thibault DEGAND, MD', 'role': 'CONTACT', 'email': 'thibault.degand@chu-dijon.fr'}], 'facility': 'University Hospital of Dijon', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '87042', 'city': 'Limoges', 'country': 'France', 'contacts': [{'name': 'Jeremy JACQUES, MD, PhD', 'role': 'CONTACT', 'email': 'jeremie.jacques@chu-limoges.fr'}], 'facility': 'University Hospital of Limoges', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '69003', 'city': 'Lyon', 'country': 'France', 'contacts': [{'name': 'Mathieu PIOCHE, MD, PhD', 'role': 'CONTACT', 'email': 'mathieu.pioche@chu-lyon.fr'}], 'facility': 'Civil Hospices of Lyon', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '69008', 'city': 'Lyon', 'country': 'France', 'contacts': [{'name': 'Sarah LEBLANC, MD', 'role': 'CONTACT', 'email': 'sarahleblanc34@hotmail.com'}], 'facility': 'Jean Mermoy Private Hospital', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '34095', 'city': 'Montpellier', 'country': 'France', 'contacts': [{'name': 'Antoine DEBOURDEAU, MD', 'role': 'CONTACT', 'email': 'a-debourdeau@chu-montpellier.fr'}], 'facility': 'University Hospital of Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '54511', 'city': 'Nancy', 'country': 'France', 'contacts': [{'name': 'SCHAEFFER Marion, MD', 'role': 'CONTACT', 'email': 'M.SCHAEFER@chru-nancy.fr'}], 'facility': 'University Hospital of Nancy', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}, {'zip': '30029', 'city': 'Nîmes', 'country': 'France', 'contacts': [{'name': 'Ludovic CAILLO, MD', 'role': 'CONTACT', 'email': 'ludovic.caillo@chu-nimes.fr'}], 'facility': 'University Hospital of Nîmes', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'zip': '75014', 'city': 'Paris', 'country': 'France', 'contacts': [{'name': 'Yann LE BALEUR, MD', 'role': 'CONTACT', 'email': 'ylebaleur@ghpsj.fr'}], 'facility': 'Saint Joseph Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '35033', 'city': 'Rennes', 'country': 'France', 'contacts': [{'name': 'Timothée WALLENHORST, MD', 'role': 'CONTACT', 'email': 'Timothee.WALLENHORST@chu-rennes.fr'}], 'facility': 'University Hospital of Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}], 'centralContacts': [{'name': 'Antoine DEBOURDEAU, MD', 'role': 'CONTACT', 'email': 'a-debourdeau@chu-montpellier.fr', 'phone': '+334.67.33.07.83'}, {'name': 'Catherine PANABIERES, MD, PhD', 'role': 'CONTACT', 'email': 'c-panabieres@chu-montpellier.fr'}], 'overallOfficials': [{'name': 'Antoine DEBOURDEAU, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital, Montpellier'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital, Limoges', 'class': 'OTHER'}, {'name': 'Société Nationale Française de Gastroentérologie', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}