NCT05856825

Brief Summary

A multicenter, retrospective research was conducted. Patients who underwent robot-assisted radical cystectomy (RARC) from for bladder cancer in 32 institutions in China were enrolled in this study. Baseline condition, perioperative, pathological, and survival outcome were collected. The study was aimed to report the real-world condition of RARC in China, and evaluate its effectiveness.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2023

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2023

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

May 4, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 12, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

May 12, 2023

Status Verified

May 1, 2023

Enrollment Period

8 months

First QC Date

May 4, 2023

Last Update Submit

May 4, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • Overall survival

    Time from surgery until death from any cause

    Five years

  • Recurrence-free survival

    Time from surgery to tumor recurrence which identified either pathologically or radiographically

    Five years

  • Cancer-specific survival

    Time from date of surgery to death due to bladder cancer

    Five years

Study Arms (32)

Sun Yat-sen Memorial Hospital

Procedure: Robot-assisted radical cystectomy

Renji Hospital, Shanghai Jiaotong University School of Medicine

Procedure: Robot-assisted radical cystectomy

The Third Medical Centre of Chinese PLA General Hospital

Procedure: Robot-assisted radical cystectomy

The First Affiliated Hospital of Zhengzhou University

Procedure: Robot-assisted radical cystectomy

Zhejiang Provincial People's Hospital, Affiliated People's Hospital, Hangzhou Medical College

Procedure: Robot-assisted radical cystectomy

Southwest Hospital, Third Military Medical Hospital (Army Medical University)

Procedure: Robot-assisted radical cystectomy

Tongji Hospital Affiliated to Tongji Medical College Hust

Procedure: Robot-assisted radical cystectomy

The First Affiliated Hospital of Xi'an Jiaotong University

Procedure: Robot-assisted radical cystectomy

The First Affiliated Hospital of Navy Medical University

Procedure: Robot-assisted radical cystectomy

The First Affiliated Hospital of Nanchang University

Procedure: Robot-assisted radical cystectomy

Zhongda Hospital Southeast University

Procedure: Robot-assisted radical cystectomy

The Second Xiangya Hospital, Central South University

Procedure: Robot-assisted radical cystectomy

The First Affiliated Hospital of Nanjing Medical University

Procedure: Robot-assisted radical cystectomy

Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital

Procedure: Robot-assisted radical cystectomy

Gansu Provincial Hospital

Procedure: Robot-assisted radical cystectomy

The Affiliated Yantai Yuhuangding Hospital of Qingdao University

Procedure: Robot-assisted radical cystectomy

West China Hospital, Sichuan University

Procedure: Robot-assisted radical cystectomy

The First Hospital of China Medical University

Procedure: Robot-assisted radical cystectomy

The Third Xiangya Hospital of Central South University

Procedure: Robot-assisted radical cystectomy

General Hospital of Central Theater Command

Procedure: Robot-assisted radical cystectomy

Kunming First People's Hospital

Procedure: Robot-assisted radical cystectomy

The East Campus of Qingdao Municipal Hospital

Procedure: Robot-assisted radical cystectomy

The second Affiliated Hospital of Kunming Medical University

Procedure: Robot-assisted radical cystectomy

Second Hospital of Dalian Medical University

Procedure: Robot-assisted radical cystectomy

The Second Affiliated Hospital of Xi'an Jiaotong University

Procedure: Robot-assisted radical cystectomy

The First Hospital of Jilin University

Procedure: Robot-assisted radical cystectomy

Zhejiang Cancer Hospital

Procedure: Robot-assisted radical cystectomy

Peking University Third Hospital

Procedure: Robot-assisted radical cystectomy

Changzheng Hospital, Naval Medical University

Procedure: Robot-assisted radical cystectomy

Peking Union Medical College Hospital

Procedure: Robot-assisted radical cystectomy

The First Affiliated Hospital of Chongqing Medical University

Procedure: Robot-assisted radical cystectomy

Beijing United Family Hospital and Clinics

Procedure: Robot-assisted radical cystectomy

Interventions

Robot-assisted radical cystectomy

Beijing United Family Hospital and ClinicsChangzheng Hospital, Naval Medical UniversityGansu Provincial HospitalGeneral Hospital of Central Theater CommandKunming First People's HospitalPeking Union Medical College HospitalPeking University Third HospitalRenji Hospital, Shanghai Jiaotong University School of MedicineSecond Hospital of Dalian Medical UniversitySichuan Academy of Medical Sciences & Sichuan Provincial People's HospitalSouthwest Hospital, Third Military Medical Hospital (Army Medical University)Sun Yat-sen Memorial HospitalThe Affiliated Yantai Yuhuangding Hospital of Qingdao UniversityThe East Campus of Qingdao Municipal HospitalThe First Affiliated Hospital of Chongqing Medical UniversityThe First Affiliated Hospital of Nanchang UniversityThe First Affiliated Hospital of Nanjing Medical UniversityThe First Affiliated Hospital of Navy Medical UniversityThe First Affiliated Hospital of Xi'an Jiaotong UniversityThe First Affiliated Hospital of Zhengzhou UniversityThe First Hospital of China Medical UniversityThe First Hospital of Jilin UniversityThe Second Affiliated Hospital of Xi'an Jiaotong UniversityThe Second Xiangya Hospital, Central South UniversityThe Third Medical Centre of Chinese PLA General HospitalThe Third Xiangya Hospital of Central South UniversityThe second Affiliated Hospital of Kunming Medical UniversityTongji Hospital Affiliated to Tongji Medical College HustWest China Hospital, Sichuan UniversityZhejiang Cancer HospitalZhejiang Provincial People's Hospital, Affiliated People's Hospital, Hangzhou Medical CollegeZhongda Hospital Southeast University

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who underwent robot-assisted radical cystectomy for bladder cancer from 2012 to 2021 in 32 large medical institutions in China.

You may qualify if:

  • \>18 years old; Clinical stage Ta-T4a/N0-3/M0.

You may not qualify if:

  • Severe cardiovascular disease; history of previous major abdominopelvic surgery; patients with distant metastases; medical history of malignancy in other organs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2023

First Posted

May 12, 2023

Study Start

May 1, 2023

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

May 12, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share