Ignite Creation Date:
2025-12-24 @ 9:29 PM
Ignite Modification Date:
2026-04-01 @ 12:53 PM
Study NCT ID:
NCT04184232
Status:
COMPLETED
Last Update Posted:
2021-01-22
First Post:
2019-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Recurrent Bladder Cancer With Dendritic Cells
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-20', 'studyFirstSubmitDate': '2019-12-01', 'studyFirstSubmitQcDate': '2019-12-01', 'lastUpdatePostDateStruct': {'date': '2021-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy evaluation', 'timeFrame': '1 year', 'description': '1 year relapse free survival'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bladder Cancer', 'Dendritic cells'], 'conditions': ['Bladder Cancer']}, 'descriptionModule': {'briefSummary': 'Treatment of recurrent bladder cancer with dendritic cells'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed diagnosis of pTa bladder cancer;\n* Patient who require repetitive transurethral resection;\n* Expression of muc-1/wt-1 by the tumor;\n* EGOC 0-3;\n\nExclusion Criteria:\n\n* any medical condition which can be associated with the high risk for the patient;\n* pregnancy/lactation;\n* chronic infections, including hepatitis B/C, tuberculosis, HIV'}, 'identificationModule': {'nctId': 'NCT04184232', 'briefTitle': 'Treatment of Recurrent Bladder Cancer With Dendritic Cells', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus'}, 'officialTitle': 'Treatment of Recurrent Bladder Cancer With Autologous Monocyte-derived Dendritic Cells', 'orgStudyIdInfo': {'id': 'IBCE_DC1(BLAD)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dendritic cells', 'description': 'Patients with the recurrent bladder cancer receiving standard treatment and autologous dendritic cells', 'interventionNames': ['Biological: Dendritic cells', 'Other: Standard treatment according to the Clinical protocols']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Patients with the recurrent bladder cancer receiving standard treatment', 'interventionNames': ['Other: Standard treatment according to the Clinical protocols']}], 'interventions': [{'name': 'Dendritic cells', 'type': 'BIOLOGICAL', 'description': 'Autologous dendritic cells primed with muc-1/wt-1 peptides', 'armGroupLabels': ['Dendritic cells']}, {'name': 'Standard treatment according to the Clinical protocols', 'type': 'OTHER', 'description': 'Standard treatment of bladder cancer according to the Clinical protocols', 'armGroupLabels': ['Control', 'Dendritic cells']}]}, 'contactsLocationsModule': {'locations': [{'zip': '220072', 'city': 'Minsk', 'country': 'Belarus', 'facility': 'Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus', 'geoPoint': {'lat': 53.90019, 'lon': 27.56653}}], 'overallOfficials': [{'name': 'Andrei Hancharou, Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Director, the Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus'}, {'name': 'Alexander V Prokharau, Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Head of the chair, Belarusian State Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Belarusian State Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}