Ignite Creation Date:
2025-12-25 @ 12:55 AM
Ignite Modification Date:
2025-12-26 @ 1:42 PM
Study NCT ID:
NCT05742867
Status:
COMPLETED
Last Update Posted:
2025-01-23
First Post:
2023-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate Treatment Preferences for Japanese Participants With Muscle-invasive Urothelial Carcinoma of the Bladder
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 115}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-07-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-21', 'studyFirstSubmitDate': '2023-02-01', 'studyFirstSubmitQcDate': '2023-02-14', 'lastUpdatePostDateStruct': {'date': '2025-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'Up to 1 year after radical cystectomy', 'description': 'Median overall survival (years)'}, {'measure': '5-year survival rate', 'timeFrame': 'Up to 1 year after radical cystectomy', 'description': 'Defined as the percentage of patients that are alive after 5 years'}, {'measure': 'Disease-free survival (DFS)', 'timeFrame': 'Up to 1 year after radical cystectomy', 'description': 'Median disease-free survival (year)'}, {'measure': 'Probability of side effect-related treatment discontinuation', 'timeFrame': 'Up to 1 year after radical cystectomy', 'description': 'Defined as the percent likelihood that a patient will stop treatment due to a side effect'}, {'measure': 'Number of participants who experience treatment side effects', 'timeFrame': 'Up to 1 year after radical cystectomy', 'description': 'Defined as the percentage of participants who experience nausea, diarrhea, fatigue, skin-related side effects (e.g. pruritus, rash), endocrine system-related side effects (e.g. hypothyroidism), anemia, alopecia, reduced renal function, cardiac impairment, leukopenia, neutropenia, and thrombocytopenia due to treatment'}, {'measure': 'Overall severity of side effects', 'timeFrame': 'Up to 1 year after radical cystectomy', 'description': 'Defined as the severity of side effects categorized as "None", "mild-to-moderate", or "severe"'}, {'measure': 'Treatment Convenience', 'timeFrame': 'Up to 1 year after radical cystectomy', 'description': 'Defined as the route of administration and frequency of administration per day or week (Infusions once every week, 2 weeks, or 4 weeks)'}, {'measure': 'Treatment duration', 'timeFrame': 'Up to 1 year after radical cystectomy', 'description': 'Defined as the total duration for continuous administration of treatment categorized as 2 months, 4 months, or 1 year'}, {'measure': 'Hospitalization', 'timeFrame': 'Up to 1 year after radical cystectomy', 'description': 'Defined as the length of hospitalization required for administration of treatment categorized as 0 days (no hospitalization required for administration of treatment), 1 week, or more than 1 week'}, {'measure': 'Frequency of outpatient consultations', 'timeFrame': 'Up to 1 year after radical cystectomy', 'description': 'Defined as the number of outpatient consultations required for treatment administration and monitoring categorized as every 2 weeks, 4 weeks, or 3 months'}, {'measure': 'Annual treatment costs', 'timeFrame': 'Up to 1 year after radical cystectomy', 'description': 'Defined as the annual out-of-pocket treatment costs, categorized as 10,000, 300,000, or 650,000 JPY'}]}, 'conditionsModule': {'conditions': ['Urinary Bladder Neoplasms']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'Investigator Inquiry Form'}, {'url': 'https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm', 'label': 'FDA Safety Alerts and Recalls'}, {'url': 'https://www.bmsstudyconnect.com/s/US/English/USenHome', 'label': 'BMS Clinical Trial Patient Recruiting'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to identify important treatment attributes for post-radical cystectomy (RC) treatment for participants with MIBC (Muscle-Invasive Bladder Cancer) and assess the relative importance of treatment attributes for post-RC treatment in Japan.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study population is composed of 115 Japanese participants, 18 years and older, with muscle-invasive urothelial carcinoma of the bladder following radical cystectomy.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must reside in Japan and able to speak/read Japanese for the interview/survey\n* Must have a clinical diagnosis of Muscle-invasive bladder cancer (MIBC):\n\n * ypT2-ypT4a or ypN+ MIBC, with prior neoadjuvant cisplatin chemotherapy and underwent radical cystectomy\n * pT3-pT4a or pN+ MIBC, without prior neoadjuvant cisplatin chemotherapy and underwent radical cystectomy\n* Must not have received any treatment related to MIBC after radical cystectomy\n\nExclusion Criteria:\n\n* Determined by the physician as being unsuitable for the study (e.g. having any clinically significant psychiatric disorder, cognitive impairment, or having difficulty with communicating in Japanese)\n* Confirmed diagnosis of other primary cancers at the time of obtaining consent\n* Current participation in a MIBC clinical trial'}, 'identificationModule': {'nctId': 'NCT05742867', 'acronym': 'SNUGGLE', 'briefTitle': 'A Study to Evaluate Treatment Preferences for Japanese Participants With Muscle-invasive Urothelial Carcinoma of the Bladder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Patient Preferences of Treatment for the Patients Suffering From Muscle-invasive Urothelial Carcinoma of Bladder Following Radical Cystectomy in Japan', 'orgStudyIdInfo': {'id': 'CA209-6M4'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort 1', 'description': 'High-risk Muscle-Invasive Bladder Cancer (MIBC) participants following radical cystectomy'}]}, 'contactsLocationsModule': {'locations': [{'zip': '27560', 'city': 'Morrisville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Local Institution - 0001', 'geoPoint': {'lat': 35.82348, 'lon': -78.82556}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Ono Pharmaceutical Co. Ltd', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}