Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2026-02-25 @ 5:50 PM
Study NCT ID:
NCT04726735
Status:
COMPLETED
Last Update Posted:
2021-01-27
First Post:
2021-01-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of PD-L1 Expression and Immune Infiltration in High-risk Non Muscle Invasive Bladder Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}, {'id': 'D000093284', 'term': 'Non-Muscle Invasive 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'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'samples taken from 2007 to 2011 and stored in the tissue bank from Bordeaux hospital'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-05-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-25', 'studyFirstSubmitDate': '2021-01-19', 'studyFirstSubmitQcDate': '2021-01-25', 'lastUpdatePostDateStruct': {'date': '2021-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PD-L1 status (positive or negative) of the tumor and tumor associated immune cells.', 'timeFrame': 'Day 1', 'description': 'PD-L1 status will be considered positive if more than 25% of tumor cells exhibit membrane staining or immune cells present (ICP) \\>1% and immune cells (IC)+ \\>25% or ICP=1% and IC+ = 100%.\n\nPD-L1 status will be considered negative if none of the criteria for PD-L1 positive status are met.'}], 'secondaryOutcomes': [{'measure': 'Descriptive analysis of the differential expression of all the following immune biomarkers in normal bladder tissue, NMIBC (Non Muscle Invasive Bladder Cancer) and MIBC (Muscle Invasive Bladder Cancer).', 'timeFrame': 'Day 1', 'description': 'Descriptive statistics will be performed from clinical characteristics as mean values for categorical variables, or medians (range) for non-normal continuous variables.'}, {'measure': 'Association of immune profile with recurrence and progression rates', 'timeFrame': 'Day 1', 'description': 'Association between all variables will be analysed with t-test, Mann Whitney or ANOVA multiple comparison test. Correlation analysis will be performed with χ2 and Fischer exact test. Results will be considered significant if the p-value is \\<0.05.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Non Muscle Invasive Bladder Cancer', 'Bacillus Calmette-Guerin', 'Programmed cell Death-Ligand protein 1', 'Programmed cell Death 1', 'Muscle Invasive Bladder Cancer'], 'conditions': ['Bladder Cancer']}, 'descriptionModule': {'briefSummary': 'Non-muscle-invasive bladder cancer (NMIBC) has a high rate of recurrence (60 to 70%) and progression (20 to 30%) to muscle-invasive bladder cancer (MIBC).\n\nThe local immunotherapy (intra-vesical Bacillus Calmette-Guerin (BCG) following transurethral resection of the bladder tumor (TURBT)) reduces significantly the risk of recurrence and progression as compared to observation or to intra-vesical chemotherapy.\n\nSystemic immunotherapy with programmed death ligand-1 (PD-L1) or Programmed cell Death 1 (PD1) inhibitors has shown major efficacy in the treatment of patients with advanced/metastatic urothelial carcinoma who have progressed on platinum-based regimens of chemotherapy, or even in front line setting. In the field of NMIBC, immunotherapy using PD-L1 or PD1 inhibitors is under investigation but the frequency of PD-L1 expression has rarely been precisely described in the different subtypes.\n\nThe aim of this retrospective study is to investigate the expression of PD-L1 by different types of NMIBC.\n\nThe secondary objective is to characterize the immune contexture of NMIBC.', 'detailedDescription': 'Non-muscle-invasive bladder cancer (NMIBC) has a high rate of recurrence (60 to 70%) and progression (20 to 30%) to muscle-invasive bladder cancer (MIBC).\n\nThe local immunotherapy (intra-vesical Bacillus Calmette-Guerin (BCG) following transurethral resection of the bladder tumor (TURBT)) reduces significantly the risk of recurrence and progression as compared to observation or to intra-vesical chemotherapy.\n\nSystemic immunotherapy with programmed death ligand-1 (PD-L1) or Programmed cell Death 1 (PD1) inhibitors has shown major efficacy in the treatment of patients with advanced/metastatic urothelial carcinoma who have progressed on platinum-based regimens of chemotherapy, or even in front line setting. In the field of NMIBC, immunotherapy using PD-L1 or PD1 inhibitors is under investigation but the frequency of PD-L1 expression has rarely been precisely described in the different subtypes.\n\nThe aim of this retrospective study is to investigate the expression of PD-L1 by different types of NMIBC.\n\nThe secondary objective is to characterize the immune contexture of NMIBC. The immunological contexture of NMIBC in comparison with normal bladder tissue and invasive bladder cancer will be deciphered. The objective is to determine immune signatures associated with response or relapse/progression, with and without immune treatments in NMIBC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with histologically documented normal bladder, NMIBC (Ta, T1, CIS) or MIBC stored in the tissue bank.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients with histologically documented normal bladder, NMIBC (Ta, T1, CIS) or MIBC stored in the tissue bank.\n\nSamples collected from 2007 to 2011. 3 years follow-up is mandatory to assess the frequency of recurrences and progressions.\n\nExclusion Criteria:\n\n* History of autoimmune disease\n* Active tuberculosis\n* Prior treatment with CD137 agonists, anti-programmed death-1 (PD-1), or anti-PD-L1 therapeutic antibody or pathway-targeting agents'}, 'identificationModule': {'nctId': 'NCT04726735', 'acronym': 'IMMUN VESSIE', 'briefTitle': 'Evaluation of PD-L1 Expression and Immune Infiltration in High-risk Non Muscle Invasive Bladder Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Bordeaux'}, 'officialTitle': 'Evaluation of PD-L1 Expression and Immune Infiltration in High-risk Non Muscle Invasive Bladder Cancer', 'orgStudyIdInfo': {'id': 'CHUBX2018/55'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with histologically documented normal bladder', 'interventionNames': ['Biological: Samples of bladder tissue']}, {'label': 'Patients with histologically documented Non Muscle Invasive Bladder Cancer', 'interventionNames': ['Biological: Samples of bladder tissue']}, {'label': 'Patients with histologically documented Muscle Invasive Bladder Cancer', 'interventionNames': ['Biological: Samples of bladder tissue']}], 'interventions': [{'name': 'Samples of bladder tissue', 'type': 'BIOLOGICAL', 'description': 'Samples of bladder tissue collected between 2007 and 2011.', 'armGroupLabels': ['Patients with histologically documented Muscle Invasive Bladder Cancer', 'Patients with histologically documented Non Muscle Invasive Bladder Cancer', 'Patients with histologically documented normal bladder']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Talence', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Bordeaux', 'geoPoint': {'lat': 44.80849, 'lon': -0.58915}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Bordeaux', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Bordeaux', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}