Ignite Creation Date:
2025-12-24 @ 9:57 PM
Ignite Modification Date:
2026-01-01 @ 11:29 AM
Study NCT ID:
NCT06026332
Status:
RECRUITING
Last Update Posted:
2025-09-17
First Post:
2023-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ADSTILADRIN Early Utilization and Outcomes in the Real World Setting
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-16', 'studyFirstSubmitDate': '2023-08-30', 'studyFirstSubmitQcDate': '2023-08-30', 'lastUpdatePostDateStruct': {'date': '2025-09-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-09-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Whether or not a patient with CIS (with or without concomitant high-grade Ta or T1 papillary disease) achieves Complete Response (CR) at first evaluation from first ADSTILADRIN instillation', 'timeFrame': '3 months'}, {'measure': 'Whether or not a patient with CIS (with or without concomitant high-grade Ta or T1 papillary disease) achieves CR at any time within 1 year from first ADSTILADRIN instillation', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Duration of CR in patients with CIS (with or without concomitant high-grade Ta or T1 papillary disease) who achieve CR', 'timeFrame': 'Up to 2 years'}, {'measure': 'High-grade recurrence-free survival', 'timeFrame': 'Up to 2 years'}, {'measure': 'Incidence of being HGRF after one ADSTILADRIN instillation and incidence of being HGRF at 1 year from first ADSTILADRIN instillation', 'timeFrame': '1 year'}, {'measure': 'Incidence of and time to cystectomy', 'timeFrame': 'Up to 2 years'}, {'measure': 'Progression-free survival (PFS)', 'timeFrame': 'Up to 2 years'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to 2 years'}, {'measure': 'Mortality due to bladder cancer', 'timeFrame': 'Up to 2 years'}, {'measure': 'Prior treatments and outcomes before starting ADSTILADRIN treatment', 'timeFrame': 'Before starting ADSTILADRIN treatment'}, {'measure': 'Number of ADSTILADRIN instillations received and time intervals between instillations', 'timeFrame': 'Up to 2 years'}, {'measure': 'Reasons for discontinuation of ADSTILADRIN treatment', 'timeFrame': 'End of trial (up to 2 years)'}, {'measure': 'Concomitant therapies for bladder cancer and major comorbidities', 'timeFrame': 'Up to 2 years'}, {'measure': 'Re-treatment of non-responders with ADSTILADRIN at 3 months or when deemed appropriate by the treating physician', 'timeFrame': '3 months'}, {'measure': "Patients' caregiver experience as measured by WPAI:CG (administered at the same timepoints as the patients)", 'timeFrame': 'Up to 2 years', 'description': 'WPAI:CG is Work Productivity and Activity Impairment, as adapted for caregiving.'}, {'measure': 'Subsequent line of therapy following ADSTILADRIN discontinuation', 'timeFrame': 'Up to 2 years'}, {'measure': 'Customized patient baseline and follow-up experience surveys (before first ADSTILADRIN instillation and before each instillation thereafter)', 'timeFrame': 'Before first ADSTILADRIN instillation and before each instillation thereafter'}, {'measure': 'Quality of life surveys (EQ-5D-5L before first ADSTILADRIN instillation)', 'timeFrame': 'Before first ADSTILADRIN instillation'}, {'measure': 'Customized physician surveys (at 1 month following first patient first instillation of ADSTILADRIN, or as soon as possible upon site activation, and at 12 and 24 months post first patient first instillation at each respective site)', 'timeFrame': 'Up to 2 years', 'description': 'Domains captured will include product considerations and treatment satisfaction'}, {'measure': 'Type, incidence, relatedness to ADSTILADRIN, severity grading (National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0), and seriousness of adverse events collected', 'timeFrame': 'End of trial (up to 2 years)'}, {'measure': 'Proportion of patients with pre-specified biomarker tested in the routine care setting, along with timing, type of sampling and laboratory results', 'timeFrame': 'End of trial (up to 2 years)', 'description': 'Routine care setting e.g., Cxbladder Detec, UroVysion FISH, nuclear matrix protein 22 (NMP22) and bladder tumor antigen (BTA) tests\\]'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bladder cancer', 'NMIBC', 'CIS', 'Ta/T1', 'BCG Unresponsive', 'Vesical instillation treatment'], 'conditions': ['Bladder Cancer']}, 'descriptionModule': {'briefSummary': 'Multi-center, prospective non-interventional study to collect data on the early use of Adstiladrin in the US and Israel. Data will be collected from patients and prescribing physicians in a real-world setting'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants who have been prescribed Ferring ADSTILADRIN at the participating sites will be enrolled.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Prescribed and scheduled treatment with ADSTILADRIN per physician discretion or received the first instillation of ADSTILADRIN per physician discretion after 5 September 2023 but prior to site activation\n* Signed and dated ICF.\n* Age 18 years or older at day ICF is signed.\n\nExclusion Criteria:\n\n* Currently enrolled in a clinical trial.\n* Participants who have previously been treated with ADSTILADRIN in the context of a clinical trial\n* Participant is pregnant or breastfeeding.'}, 'identificationModule': {'nctId': 'NCT06026332', 'acronym': 'ABLE-41', 'briefTitle': 'ADSTILADRIN Early Utilization and Outcomes in the Real World Setting', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ferring Pharmaceuticals'}, 'officialTitle': 'ADSTILADRIN Early Utilization and Outcomes in the Real World Setting', 'orgStudyIdInfo': {'id': '000431'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ADSTILADRIN', 'interventionNames': ['Drug: ADSTILADRIN']}], 'interventions': [{'name': 'ADSTILADRIN', 'type': 'DRUG', 'otherNames': ['Nadofaragene Firadenovec'], 'description': 'Non-interventional', 'armGroupLabels': ['ADSTILADRIN']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85234', 'city': 'Gilbert', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Banner Health MD Anderson Cancer Center', 'geoPoint': {'lat': 33.35283, 'lon': -111.78903}}, {'zip': '85054', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Mayo Clinic Arizona', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '72211', 'city': 'Little Rock', 'state': 'Arkansas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Arkansas Urology, North Little Rock', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '93720', 'city': 'Fresno', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Urology Associates of Central California', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'USC Norris Comprehensive Cancer Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'UF Health Surgical Specialists - Gainesville', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '32225', 'city': 'Jacksonville', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33140', 'city': 'Miami Beach', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Mount Sinai Medical Center', 'geoPoint': {'lat': 25.79065, 'lon': -80.13005}}, {'zip': '33578', 'city': 'Riverview', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Florida Urology Partners', 'geoPoint': {'lat': 27.86614, 'lon': -82.32648}}, {'zip': '33701', 'city': 'St. Petersburg', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Florida Urology Partners', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '33607', 'city': 'Tampa', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Florida Urology Partners', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33615', 'city': 'Tampa', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Florida Urology Partners', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30328', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Georgia Urology', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '46143', 'city': 'Greenwood', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Global Clinical Compliance', 'role': 'CONTACT'}], 'facility': 'UROLOGY OF INDIANA - GREENWOOD FQ: Urology of Indiana US Uro Partners', 'geoPoint': {'lat': 39.61366, 'lon': -86.10665}}, {'zip': '47130', 'city': 'Jeffersonville', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'First Urology Research (Jeffersonville)', 'geoPoint': {'lat': 38.27757, 'lon': -85.73718}}, {'zip': '67226', 'city': 'Wichita', 'state': 'Kansas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Wichita Urology - Wichita Webb', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Johns Hopkins Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Mayo Clinic - Rochester Minnesota', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '55125', 'city': 'Woodbury', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Minnesota Urology', 'geoPoint': {'lat': 44.92386, 'lon': -92.95938}}, {'zip': '68114', 'city': 'Omaha', 'state': 'Nebraska', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'The Urology Center, PC', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '13210', 'city': 'Syracuse', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'AMP UROLOGY, Syracuse - US Urology Partners', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'zip': '13210', 'city': 'Syracuse', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'SUNY Upstate Medical University Syracuse', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'zip': '10461', 'city': 'The Bronx', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Montefiore Medical Center (Bronx2)', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '43230', 'city': 'Gahanna', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Central OH Urology Group - US Urology Partners', 'geoPoint': {'lat': 40.01923, 'lon': -82.87934}}, {'zip': '29579', 'city': 'Myrtle Beach', 'state': 'South Carolina', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Atlantic Urology Clinics - McLeod Health Blvd', 'geoPoint': {'lat': 33.68906, 'lon': -78.88669}}, {'zip': '37209', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Urology Associates P C (Nashville)', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Texas Southwestern Medical Center (Dallas)', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '84112', 'city': 'Salt Lake City', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Utah (Salt Lake City)', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Virginia Health System', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '23462', 'city': 'Virginia Beach', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Urology of Virginia (Virginia Beach)', 'geoPoint': {'lat': 36.85293, 'lon': -75.97799}}], 'centralContacts': [{'name': 'Global Clinical Compliance', 'role': 'CONTACT', 'email': 'MedqueriesUS@ferring.com', 'phone': '1-888-FERRING (1-888-337-7464)'}, {'name': 'Global Clinical Compliance', 'role': 'CONTACT', 'email': 'DK0-Disclosure@ferring.com', 'phone': '+1 862-286-5200 (outside US)'}], 'overallOfficials': [{'name': 'Global Clinical Compliance', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ferring Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ferring Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}