Gene expression in bladder cancer and normal tissues

ISRCTN ISRCTN10601218
DOI https://doi.org/10.1186/ISRCTN10601218
Secondary identifying numbers CPMS2023
Submission date
21/12/2024
Registration date
26/02/2025
Last edited
06/01/2025
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
In this study, patients with bladder cancer were examined to analyze the levels of RBM15 in both cancerous and normal tissues. The goal was to identify potential therapeutic targets that could be used to treat bladder cancer more effectively.

Who can participate?
Patients diagnosed with bladder cancer

What does the study involve?
Participants joined the study starting in March 2018 and for 6 years. This study collects tissue samples at the time of surgery and follows participants for 6 years. Patients are followed up annually by telephone for survival. Cancerous and normal tissues were collected from patients with bladder cancer.

What are the possible benefits and risks of participating?
The study team provided 1000 RMB as compensation for each patient. In this study, the discarded tumor tissue was removed during the patient's operation, which did not affect the body and no other participation risks were anticipated.

Where is the study run from?
The study was conducted in Affiliated Haikou Hospital of Xiangya Medical College

When is the study starting and how long is it expected to run for?
March 2022 to June 2024

Who is funding the study?
1. Finance Science and Technology Project of Hainan Province
2. National Science Foundation of China
3. Health Department of Hainan Province

Who is the main contact?
Shufang Zhang, zsf_99900023@csu.edu.cn

Contact information

Prof Shufang Zhang
Public, Scientific, Principal Investigator

No.43 Renmin Avenue
Haikou
570208
China

ORCiD logoORCID ID 0009-0000-7203-665X
Phone +86 089866289665
Email zsf_99900023@csu.edu.cn
Dr Mei Chen
Public, Principal Investigator

No.43 Renmin Avenue
Haikou
570208
China

Phone +86 15243653187
Email meichen_cns@163.com

Study information

Study designObservational cohort study
Primary study designObservational
Secondary study designCohort study
Study setting(s)Internet/virtual, Laboratory, Telephone
Study typeTreatment
Participant information sheet No participant information sheet available
Scientific titleBladder cancer and normal tissues
Study objectivesExpression of RBM15 in bladder cancer and normal tissue
Ethics approval(s)

Approved 10/03/2022, Haikou Municipal People's Hospital Biomedical Ethics Committee (No.43 Renmin Avenue, Haikou, 570208, China; +86 089866189665; zsf66189665@126.com), ref: 2023-055

Health condition(s) or problem(s) studiedBladder cancer
InterventionThis study enrols patients with bladder cancer, collects tissue samples at the time of surgery, and follows them for 6 years. Patients are followed up annually by telephone for survival.

Cancerous and normal tissues were collected from patients with bladder cancer.
Intervention typeOther
Primary outcome measureSurvival measured using data collected at an annual telephone call for 6 years
Secondary outcome measuresTransfer or not measured using data collected during a telephone call every 6 months
Overall study start date10/03/2022
Completion date12/06/2024

Eligibility

Participant type(s)Patient
Age groupMixed
SexBoth
Target number of participants67
Key inclusion criteriaPatients who were diagnosed with bladder cancer
Key exclusion criteriaPatients with other cancers
Date of first enrolment11/05/2022
Date of final enrolment01/06/2024

Locations

Countries of recruitment

  • China

Study participating centre

Affiliated Haikou Hospital of Xiangya Medical College
No.43 Renmin Avenue
Haikou
570208
China

Sponsor information

Affiliated Haikou Hospital of Xiangya Medical College
Hospital/treatment centre

No.43 Renmin Avenue
Haikou
570208
China

Phone +86 089866189663
Email zsf66189665@126.com
Website https://www.haikoumh.com.cn/

Funders

Funder type

Government

Hainan Provincial Department of Science and Technology
Government organisation / Local government
Alternative name(s)
海南省科学技术厅, Department of Science and Technology of Hainan Province
Location
China
National Natural Science Foundation of China
Government organisation / National government
Alternative name(s)
Chinese National Science Foundation, Natural Science Foundation of China, National Science Foundation of China, NNSF of China, NSF of China, 国家自然科学基金委员会, National Nature Science Foundation of China, Guójiā Zìrán Kēxué Jījīn Wěiyuánhuì, NSFC, NNSF, NNSFC
Location
China
Hainan Provincial Department of Health
Government organisation / Local government
Alternative name(s)
海南省卫生厅, Department of Health, Hainan Province, Hainan Health Department
Location
China

Results and Publications

Intention to publish date12/06/2025
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in a peer-reviewed journal
IPD sharing planThe datasets generated during and/or analysed during the current study will be available upon request from Shufang Zhang, zsf_99900023@csu.edu.cn

Editorial Notes

03/01/2025: Study's existence confirmed by the Haikou Municipal People's Hospital Biomedical Ethics Committee.