Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2026-03-06 @ 9:43 PM
Study NCT ID:
NCT02075060
Status:
UNKNOWN
Last Update Posted:
2017-04-06
First Post:
2014-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Immediate Preoperative Instillation (IPOI) of Mitomycin C Compared to Early Postoperative Instillation (IPOP) in 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011184', 'term': 'Postoperative Period'}], 'ancestors': [{'id': 'D059035', 'term': 'Perioperative Period'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 54}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2018-01-18', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-04-04', 'studyFirstSubmitDate': '2014-02-27', 'studyFirstSubmitQcDate': '2014-02-28', 'lastUpdatePostDateStruct': {'date': '2017-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-03-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PFS', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['low-grade', 'NMIBC'], 'conditions': ['Non Muscle-invasive Bladder Cancer']}, 'descriptionModule': {'briefSummary': 'The aim of this pilot study is to assess the efficacy and toxicity of immediate pre-operative instillation of mitomycin C compared to the standard early post-operative .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years,\n* Primary or recurrent bladder tumor with endoscopic papillary aspect,\n* One or two bladder tumors,\n* Cytology before TURB showing no high-grade cells,\n* Patients without tutorship or subordination (ou curatorship),\n* Patients under the general social security system or qualifying through a third party,\n* Informed consent signed by the patient after clear and fair information.\n\nExclusion Criteria:\n\n* Age \\< 18 years,\n* Allergy to mitomycin C,\n* Traumatic stenting,\n* Upper tract urothelial cancer,\n* Urethral invasion,\n* History of muscle invasive bladder cancer,\n* Extensive tumor (3 cm or more),\n* Any contraindication to TURB,\n* Simultaneous participation in another clinical research study,\n* Patients not insured by the social security or not qualifying through a third party,\n* Patients with enhanced protection, namely pregnant or lactating women, persons deprived of their liberty by a judicial or administrative decision, people staying in a health or social institution, adults under legal protection, and finally patients in emergency situations,\n* Pregnant or lactating females or women of childbearing potential not willing to use an adequate method of birth control for the duration of the study (i.e. hormonal / mechanical contraceptive : oral, injectable, transdermal, implantable, intrauterine or surgical device: tubal ligation, hysterectomy, total oophorectomy).'}, 'identificationModule': {'nctId': 'NCT02075060', 'acronym': 'IPOI vs IPOP', 'briefTitle': 'Evaluation of Immediate Preoperative Instillation (IPOI) of Mitomycin C Compared to Early Postoperative Instillation (IPOP) in Non-muscle Invasive Bladder Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Poitiers University Hospital'}, 'orgStudyIdInfo': {'id': 'IPOI vs IPOP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IPOI', 'description': 'One arm with pre-operative instillation of mitomycine 1h before TURB (IPOI : Instillation pré-opératoire immédiate),', 'interventionNames': ['Procedure: IPOI (pre-operative)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'IPOP', 'description': 'One arm with early post-operative instillation of mitomycine within 24 hours (IPOP : Instillation Post Opératoire Précoce).', 'interventionNames': ['Procedure: IPOP (post-operative)']}], 'interventions': [{'name': 'IPOI (pre-operative)', 'type': 'PROCEDURE', 'armGroupLabels': ['IPOI']}, {'name': 'IPOP (post-operative)', 'type': 'PROCEDURE', 'armGroupLabels': ['IPOP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94270', 'city': 'Le Kremlin-Bicêtre', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Geraldine PIGNOT, MD', 'role': 'CONTACT', 'email': 'gg_pignot@yahoo.fr', 'phone': '+33-1 45 21 36 98'}], 'facility': 'Bicêtre Hospital', 'geoPoint': {'lat': 48.81471, 'lon': 2.36073}}, {'zip': '86100', 'city': 'Poitiers', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jacques IRANI, MD, PhD', 'role': 'CONTACT', 'email': 'jacques.irani@chu-poitiers.fr', 'phone': '+33 (0)5.49.44.44.77'}, {'name': 'Jacques IRANI, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Poitiers University Hospital', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'zip': '76000', 'city': 'Rouen', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'France', 'facility': 'Rouen University Hospital', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}], 'centralContacts': [{'name': 'Jacques IRANI, MD, PhD', 'role': 'CONTACT', 'email': 'jacques.irani@chu-poitiers.fr', 'phone': ': +33 (0)5.49.44.44.77'}], 'overallOfficials': [{'name': 'Jacques IRANI, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Poitiers University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Poitiers University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}