Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2026-01-27 @ 12:00 PM
Study NCT ID:
NCT05885204
Status:
UNKNOWN
Last Update Posted:
2023-06-01
First Post:
2023-05-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RARC vs LRC in A Multicenter Cohort Study
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': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3815}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-23', 'studyFirstSubmitDate': '2023-05-23', 'studyFirstSubmitQcDate': '2023-05-23', 'lastUpdatePostDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': 'Five years', 'description': 'Time from surgery until death from any cause.'}, {'measure': 'Recurrence-free Survival', 'timeFrame': 'Five years', 'description': 'Time from surgery to tumor recurrence which identified either pathologically or radiographically.'}, {'measure': 'Cancer-specific Survival', 'timeFrame': 'Five years', 'description': 'Time from date of surgery to death from bladder cancer.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bladder cancer', 'Radical cystectomy', 'Robot-assisted laparoscopy', 'Conventional laparoscopy'], 'conditions': ['Bladder Cancer']}, 'descriptionModule': {'briefSummary': 'A multicenter, retrospective research was conducted. Patients who underwent robot-assisted radical cystectomy and laparoscopic radical cystectomy in 10 large medical centers in China were enrolled, comparing the oncologic outcomes of the patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who underwent robot-assisted radical cystectomy or laparoscopic radical cystectomy for bladder cancer from 2012 to 2021 in 10 large tertiary hospitals', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>18 years old; Clinical stage Ta-T4a/N0-3/M0\n\nExclusion Criteria:\n\n* Severe cardiovascular disease; History of previous major abdominopelvic surgery; Patients with distant metastases; Medical history of malignancy in other organs.'}, 'identificationModule': {'nctId': 'NCT05885204', 'briefTitle': 'RARC vs LRC in A Multicenter Cohort Study', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University'}, 'officialTitle': 'Robot-Assisted Versus Conventional Laparoscopic Radical Cystectomy in A Multicenter Cohort Study: A Propensity Score Matching Analysis', 'orgStudyIdInfo': {'id': 'SYSKY-2023-353-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Sun Yat-sen Memorial Hospital', 'interventionNames': ['Procedure: Robot-assisted radical cystectomy', 'Procedure: Conventional laparoscopic radical cystectomy']}, {'label': 'Renji Hospital, Shanghai Jiaotong University School of Medicine', 'interventionNames': ['Procedure: Robot-assisted radical cystectomy', 'Procedure: Conventional laparoscopic radical cystectomy']}, {'label': 'The Third Medical Centre of Chinese PLA General Hospital', 'interventionNames': ['Procedure: Robot-assisted radical cystectomy', 'Procedure: Conventional laparoscopic radical cystectomy']}, {'label': 'The First Affiliated Hospital of Nanchang University', 'interventionNames': ['Procedure: Robot-assisted radical cystectomy', 'Procedure: Conventional laparoscopic radical cystectomy']}, {'label': 'Peking University Third Hospital', 'interventionNames': ['Procedure: Robot-assisted radical cystectomy', 'Procedure: Conventional laparoscopic radical cystectomy']}, {'label': 'The Second Xiangya Hospital, Central South University', 'interventionNames': ['Procedure: Robot-assisted radical cystectomy', 'Procedure: Conventional laparoscopic radical cystectomy']}, {'label': 'Zhongda Hospital Southeast University', 'interventionNames': ['Procedure: Robot-assisted radical cystectomy', 'Procedure: Conventional laparoscopic radical cystectomy']}, {'label': 'The First Hospital of Jilin University', 'interventionNames': ['Procedure: Robot-assisted radical cystectomy', 'Procedure: Conventional laparoscopic radical cystectomy']}, {'label': 'Second Hospital of Dalian Medical University', 'interventionNames': ['Procedure: Robot-assisted radical cystectomy', 'Procedure: Conventional laparoscopic radical cystectomy']}, {'label': 'Gansu Provincial Hospital', 'interventionNames': ['Procedure: Robot-assisted radical cystectomy', 'Procedure: Conventional laparoscopic radical cystectomy']}], 'interventions': [{'name': 'Robot-assisted radical cystectomy', 'type': 'PROCEDURE', 'description': 'Robot-assisted laparoscopic radical cystectomy', 'armGroupLabels': ['Gansu Provincial Hospital', 'Peking University Third Hospital', 'Renji Hospital, Shanghai Jiaotong University School of Medicine', 'Second Hospital of Dalian Medical University', 'Sun Yat-sen Memorial Hospital', 'The First Affiliated Hospital of Nanchang University', 'The First Hospital of Jilin University', 'The Second Xiangya Hospital, Central South University', 'The Third Medical Centre of Chinese PLA General Hospital', 'Zhongda Hospital Southeast University']}, {'name': 'Conventional laparoscopic radical cystectomy', 'type': 'PROCEDURE', 'description': 'Conventional laparoscopic radical cystectomy', 'armGroupLabels': ['Gansu Provincial Hospital', 'Peking University Third Hospital', 'Renji Hospital, Shanghai Jiaotong University School of Medicine', 'Second Hospital of Dalian Medical University', 'Sun Yat-sen Memorial Hospital', 'The First Affiliated Hospital of Nanchang University', 'The First Hospital of Jilin University', 'The Second Xiangya Hospital, Central South University', 'The Third Medical Centre of Chinese PLA General Hospital', 'Zhongda Hospital Southeast University']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Jian Huang, MD', 'role': 'CONTACT', 'email': 'huangj8@mail.sysu.edu.cn', 'phone': '+86-02034078477'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The data are not publicly available due to privacy and ethical restrictions.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}