Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2026-01-01 @ 6:03 PM
Study NCT ID:
NCT05002556
Status:
RECRUITING
Last Update Posted:
2025-04-30
First Post:
2021-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AFU Registry of the Therapeutic Management and Follow-up of Non-Muscle-Invasive Bladder Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000093284', 'term': 'Non-Muscle Invasive Bladder Neoplasms'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 8000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2033-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-25', 'studyFirstSubmitDate': '2021-08-04', 'studyFirstSubmitQcDate': '2021-08-04', 'lastUpdatePostDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2031-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence-Free Survival', 'timeFrame': '5 years', 'description': 'New bladder cancer (Whether NMIBC or MIBC).'}, {'measure': 'Performance of biomarkers', 'timeFrame': '5 years', 'description': 'To evaluate the diagnostic performance of urinary biomarkers available in France, and providing a binary result (positive: probable presence of a tumor recurrence; negative: probable absence of a tumor recurrence) correlated to the result of the bladder endoscopy performed as part of the routine care for the follow-up of NMIBC: determination of the negative and positive predictive values of biomarkers.'}], 'secondaryOutcomes': [{'measure': 'Progression-Free Survival', 'timeFrame': '5 years', 'description': 'New bladder cancer (MIBC).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non-Muscle-Invasive Bladder Cancer']}, 'descriptionModule': {'briefSummary': 'The AFU has set itself the task of setting up a register of medical practices in order to define possible improvements in the therapeutic management and follow-up of NMIBC. In order to obtain representative data, all urologists who are members of the AFU may be invited to include their patients.', 'detailedDescription': "BACKGROUND Non-muscle infiltrating bladder tumors are a cancerous pathology with an estimated incidence of 13,000 new cases/year in France. ¾ of new cases are diagnosed at a stage where the cancer is of limited extension to the urothelial mucosa and/or its underlying chorion (non-muscle-invasive bladder cancer NMIBC). The management and follow-up of NMIBCs are performed according to the best practice recommendations issued by the Cancer Committee of the French Urology Association. The risk of recurrence at 1 and 5 years for NMIBC has been estimated in clinical trials to be between 15%-61% and 31%-78%, respectively, depending on grade, stage, number, size, frequency of previous recurrence and presence of carcinoma in situ. In this context, patients should have regular endoscopic examinations to ensure the absence of tumor lesions inside their bladder. Urine cytology pathology is recommended for the detection of recurrence of NMIBC. However, the negative predictive value of this examination does not allow it to be substituted for bladder endoscopy, as the risk of not recognizing a bladder tumor, especially of low grade, is too high. To date, no urinary biomarker has been shown to be clinically useful and their use is not recommended for the non-invasive detection of endovesical tumor recurrence.\n\nUrine sampling is recommended prior to bladder endoscopy for follow-up of NMIBC to ensure urine sterility (CBEU) and to perform urine cytology in patients with high-grade NMIBC and/or carcinoma in situ.\n\nThe observational study of the clinical validity of the negative and positive predictive values of the biomarkers in a population of patients followed for a bladder tumor previously characterized is able to demonstrate the possibility of postponing the realization of the cystoscopy according to the tumoral characteristics and the treatments received by the patients.\n\nOBJECTIVES The main objective of the research will be to evaluate the diagnostic performance of biomarkers available in France, performed on a urine sample and providing a binary result (positive: probable presence of a tumor recurrence; negative: probable absence of a tumor recurrence) to the result of the bladder endoscopy performed as part of the routine care for the follow-up of NMIBC: determination of the negative and positive predictive values of biomarkers.\n\nThe secondary objectives will be to describe the anatomopathological characteristics, the pathological history and the treatments received in the population, as well as analyze demographic and regional disparities in the treatment profiles of these diseases.\n\nMATERIAL AND METHOD When the patient is included in the study, medical data relating to the patient's pathology, including all previous treatments, will be entered into the register, as well as the name and result of the biomarker carried out before the resection (biopsy). At each follow-up endoscopic examination scheduled in the patient's personalized care plan, the investigating urologist will record its date and endoscopic findings (white light bladder fibroscopy). The name and result of the urine test will also be recorded by the urologist. The performance of the test will be evaluated from these data by calculating sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) and by means of an analysis of variance (ANOVA) to explore possible differences within the test by tumor grade and stage, and according to previous endovesical treatments received.\n\nThe inclusion target is 8000 patients in France over a 3-year period."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient being monitored for a non-muscle-invasive bladder tumor and having undergone a urinary molecular test (biomarker) prior to their resection (biopsy) diagnosis or recurrence', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient being monitored for a non-muscle-invasive bladder tumor and having undergone a urinary molecular test (biomarker) prior to their resection (biopsy) diagnosis or recurrence,\n* AND adult (equal to or \\> 18 years old),\n* AND affiliated with a social security scheme in France,\n* AND whose monitoring will be carried out at the recruiting center.\n\nExclusion Criteria:\n\n* Patient being monitored for a non-urothelial bladder tumor\n* Patient refusing follow-up\n* Opposition to participation in the study\n* Adult protected by law'}, 'identificationModule': {'nctId': 'NCT05002556', 'acronym': 'TVNIM-AFU', 'briefTitle': 'AFU Registry of the Therapeutic Management and Follow-up of Non-Muscle-Invasive Bladder Cancer', 'organization': {'class': 'OTHER', 'fullName': "Association Francaise d'Urologie"}, 'officialTitle': 'AFU Registry of the Therapeutic Management and Follow-up of Non-Muscle-Invasive Bladder Cancer', 'orgStudyIdInfo': {'id': 'Registry TVNIM-AFU'}}, 'contactsLocationsModule': {'locations': [{'city': 'Beauvais', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Luu Le Van', 'role': 'CONTACT', 'email': 'l.levan@ch-beauvais.fr', 'phone': '+33'}], 'facility': 'Centre Hospitalier Beauvais Simone Veil', 'geoPoint': {'lat': 49.43333, 'lon': 2.08333}}, {'city': 'Caen', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Romain Lefranc', 'role': 'CONTACT', 'email': 'lefranc-r@chu-caen.fr', 'phone': '+33'}], 'facility': 'CHU Caen', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'city': 'Cesson-Sévigné', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Philippe Guiraud', 'role': 'CONTACT', 'email': 'pguiraud@vivalto-sante.com', 'phone': '+33'}], 'facility': 'Hôpital Privé de Sévigné', 'geoPoint': {'lat': 48.1212, 'lon': -1.603}}, {'city': 'Cornebarrieu', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Olivier Merigot de Treigny', 'role': 'CONTACT', 'email': 'laure.combes@ramsaysante.fr', 'phone': '+33'}], 'facility': 'Clinique des Cèdres', 'geoPoint': {'lat': 43.64967, 'lon': 1.32588}}, {'city': 'La Roche-sur-Yon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Constance Deboudt-Macé', 'role': 'CONTACT', 'email': 'constance.deboudt@ght85.fr', 'phone': '+33'}], 'facility': 'CHD Vendée', 'geoPoint': {'lat': 46.66974, 'lon': -1.42757}}, {'city': 'Le Kremlin-Bicêtre', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Cedric Lebacle', 'role': 'CONTACT', 'email': 'cedric.lebacle@aphp.fr', 'phone': '+33'}], 'facility': 'CHU Kremlin Bicêtre (APHP)', 'geoPoint': {'lat': 48.81471, 'lon': 2.36073}}, {'city': 'Le Puy-en-Velay', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marlene Guandalino', 'role': 'CONTACT', 'email': 'lesmontsduro@gmail.com', 'phone': '+33'}], 'facility': 'Clinique Bon Secours', 'geoPoint': {'lat': 45.04366, 'lon': 3.88523}}, {'city': 'Levallois-Perret', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Caroline Pettenati', 'role': 'CONTACT', 'email': 'caroline.pettenati@cognacq-jay.fr', 'phone': '+33'}], 'facility': 'Hopital Franco-Britannique Cognac Jay', 'geoPoint': {'lat': 48.89389, 'lon': 2.28864}}, {'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Emmanuel Deligne', 'role': 'CONTACT', 'email': 'emmanuel.deligne@ramsaysante.fr', 'phone': '+33'}], 'facility': 'Clinique de la Sauvegarde', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marc Colombel', 'role': 'CONTACT', 'email': 'marc.colombel@chu-lyon.fr', 'phone': '+33'}], 'facility': 'Hopital Edouard Heriot', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Alain Ruffion', 'role': 'CONTACT', 'email': 'alain.ruffion@chu-lyon.fr', 'phone': '+33'}], 'facility': 'Hopital Lyon Sud', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Mantes-la-Jolie', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Medhi Ariane', 'role': 'CONTACT', 'email': 'mariane@vivalto-sante.com', 'phone': '+33'}], 'facility': 'Clinique de la Région Mantaise', 'geoPoint': {'lat': 48.99048, 'lon': 1.7167}}, {'city': 'Marseille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Julien Deturmeny', 'role': 'CONTACT', 'email': 'j.deturmeny@hopital-europeen.fr', 'phone': '+33'}], 'facility': 'Hôpital privé Européen - Marseille', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Martigues', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Harry Toledano', 'role': 'CONTACT', 'email': 'Harry.TOLEDANO@ch-martigues.fr', 'phone': '+33'}], 'facility': 'Centre Hospitalier Martigues', 'geoPoint': {'lat': 43.40735, 'lon': 5.05526}}, {'city': 'Meaux', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Julien Sarkis', 'role': 'CONTACT', 'email': 'jsarkis@ghef.fr', 'phone': '+33'}], 'facility': "Grand Hôpital de l'Est-Francilien", 'geoPoint': {'lat': 48.96014, 'lon': 2.87885}}, {'city': 'Montpellier', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Gregoire Poinas', 'role': 'CONTACT', 'email': 'secretariat.uro@languedoc-mutualite.fr', 'phone': '+33'}], 'facility': 'Clinique Beau Soleil', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'city': 'Nîmes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Stephane Droupy', 'role': 'CONTACT', 'email': 'stephane.DROUPY@chu-nimes.fr', 'phone': '+33'}], 'facility': 'CHU Nimes', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Morgan Roupret', 'role': 'CONTACT', 'email': 'morgan.roupret@aphp.fr', 'phone': '+33'}], 'facility': 'Hôpital Pitié-Salpêtrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Pontoise', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Stéphane Bart', 'role': 'CONTACT', 'email': 'stephane.bart@ght-novo.fr', 'phone': '+33'}], 'facility': 'GHT Novo - CH René Dubos Pontoise', 'geoPoint': {'lat': 49.05, 'lon': 2.1}}, {'city': 'Pringy', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Olivier Skowron', 'role': 'CONTACT', 'email': 'oskowron@ch-annecygenevois.fr', 'phone': '+33'}], 'facility': 'Centre Hospitalier Annecy Genevois', 'geoPoint': {'lat': 45.94622, 'lon': 6.12608}}, {'city': 'Quint-Fonsegrives', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Benjamin Pradere', 'role': 'CONTACT', 'email': 'laure.combes@ramsaysante.fr', 'phone': '+33'}], 'facility': 'Clinique la Croix du Sud', 'geoPoint': {'lat': 43.5852, 'lon': 1.5272}}, {'city': 'Rouen', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Blandine Tamarelle', 'role': 'CONTACT', 'email': 'btamarelle@vivalto-sante.com', 'phone': '+33'}], 'facility': 'Clinique Mathilde', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'city': 'Rouen', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Benoit Malval', 'role': 'CONTACT', 'email': 'fhupel@clinique-sainthilaire.fr', 'phone': '+33'}], 'facility': 'Clinique Saint Hilaire', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'city': 'Royan', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Priscilla Leon', 'role': 'CONTACT', 'email': 'pleon@vivalto-sante.com', 'phone': '+33'}], 'facility': 'Clinique Pasteur', 'geoPoint': {'lat': 45.62811, 'lon': -1.03153}}, {'city': 'Saint-Germain-en-Laye', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Dimitri Gambachidze', 'role': 'CONTACT', 'email': 'dgambachidze@vivalto-sante.com', 'phone': '+33'}], 'facility': 'Clinique Saint Germain en laye', 'geoPoint': {'lat': 48.89643, 'lon': 2.0904}}, {'city': 'Saint-Jean', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Raphael Benhaim', 'role': 'CONTACT', 'email': 'laure.combes@ramsaysante.fr', 'phone': '+33'}], 'facility': "Clinique de l'Union", 'geoPoint': {'lat': 43.66519, 'lon': 1.50459}}, {'city': 'Suresnes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Yann Neuzillet', 'role': 'CONTACT', 'email': 'y.neuzillet@hopital.foch.com', 'phone': '+33'}], 'facility': 'Hopital Foch', 'geoPoint': {'lat': 48.87143, 'lon': 2.22929}}], 'centralContacts': [{'name': 'Yann Neuzillet', 'role': 'CONTACT', 'email': 'registres@afu.fr', 'phone': '+33145480609'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Association Francaise d'Urologie", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}