Gene expression in bladder cancer and normal tissues
| ISRCTN | ISRCTN10601218 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10601218 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | CPMS2023 |
| Sponsor | Affiliated Haikou Hospital of Xiangya Medical College |
| Funders | Hainan Provincial Department of Science and Technology, National Natural Science Foundation of China, Hainan Provincial Department of Health |
- 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
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
Public, Scientific, Principal investigator
No.43 Renmin Avenue
Haikou
570208
China
 ORCID ID |
0009-0000-7203-665X |
|---|---|
| Phone | +86 089866289665 |
| zsf_99900023@csu.edu.cn |
Public, Principal investigator
No.43 Renmin Avenue
Haikou
570208
China
| Phone | +86 15243653187 |
|---|---|
| meichen_cns@163.com |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational cohort study |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| Scientific title | Bladder cancer and normal tissues |
| Study objectives | Expression 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) studied | Bladder cancer |
| Intervention | This 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 type | Other |
| Primary outcome measure(s) | Survival measured using data collected at an annual telephone call for 6 years |
| Key secondary outcome measure(s) | Transfer or not measured using data collected during a telephone call every 6 months |
| Completion date | 12/06/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | All |
| Target sample size at registration | 67 |
| Key inclusion criteria | Patients who were diagnosed with bladder cancer |
| Key exclusion criteria | Patients with other cancers |
| Date of first enrolment | 11/05/2022 |
| Date of final enrolment | 01/06/2024 |
Locations
Countries of recruitment
- China
Study participating centre
Haikou
570208
China
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Shufang Zhang, zsf_99900023@csu.edu.cn |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
03/01/2025: Study's existence confirmed by the Haikou Municipal People's Hospital Biomedical Ethics Committee.
