Identification of gene markers associated with prognosis for patients with prostate cancer
| ISRCTN | ISRCTN11560295 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11560295 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Sichuan University |
| Funders | West China Hospital, Sichuan University, National Natural Science Foundation of China (Grant Nos. 81974099, 82170785, 81974098, 82170784), Department of Science and Technology of Sichuan Province (Grant Nos. 21GJHZ0246), Sichuan University (Grant No. 2017SCU04A17), Chengdu Science and Technology Bureau (2019-YF05-00296-SN) |
- Submission date
- 30/11/2021
- Registration date
- 01/12/2021
- Last edited
- 21/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Prostate cancer is a public health priority in men and the impact of this disease will be more pronounced with the aging of the world’s population. The aim of this study is to identify gene markers associated with the prognosis of prostate cancer to guide clinical practice.
Who can participate?
Patients with prostate cancer in The Cancer Genome Atlas Program (TCGA) and Gene Expression Omnibus (GEO) databases.
What does the study involve?
The researchers will obtain data on prostate cancer from public databases to identify genes related to the prognosis of prostate cancer.
What are the possible benefits and risks of participating?
There are no expected benefits or risks for the participants.
Where is the study run from?
Sichuan University (China)
When is the study starting and how long is it expected to run for?
November 2021 to December 2021
Who is funding the study?
1. National Natural Science Foundation of China (China)
2. Science and Technology Department of Sichuan Province (China)
3. Sichuan University (China)
4. Chengdu Science and Technology Bureau (China)
5. West China Hospital, Sichuan University (China)
Who is the main contact?
Prof. Lu Yang
wycleflue@163.com
Contact information
Scientific
Department of Urology
Institute of Urology
West China Hospital
Sichuan University
Guoxue Xiang #37
Chengdu
610041
China
| Phone | +86 17781480258 |
|---|---|
| wycleflue@163.com |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Retrospective observational study |
| Secondary study design | Cross sectional study |
| Study type | Participant information sheet |
| Scientific title | Prognostic biomarkers in prostate cancer identified through bioinformatic analysis |
| Study acronym | PBPCBA |
| Study objectives | The prognosis of prostate cancer can be predicted by gene markers. |
| Ethics approval(s) | All data is derived from public databases, such as The Cancer Genome Atlas Program (TCGA) and Gene Expression Omnibus (GEO) databases. Thus, ethics approval is not required. |
| Health condition(s) or problem(s) studied | Prognostic markers of prostate cancer |
| Intervention | The Genematrix and clinical data of prostate cancer patients are extracted from the TCGA and GEO databases to compare tumor and normal tissue samples. Univariate and multivariate COX regression analysis is conducted to identify independent factors associated with biochemical recurrence and metastasis. |
| Intervention type | Other |
| Primary outcome measure(s) |
Genes associated with biochemical recurrence, identified through bioinformatic analysis of data obtained from the TCGA and GEO database from 01/12/2021 to 05/12/2021 |
| Key secondary outcome measure(s) |
There are no secondary outcome measures |
| Completion date | 10/12/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target sample size at registration | 1000 |
| Total final enrolment | 3000 |
| Key inclusion criteria | Patients with prostate cancer in the TCGA and GEO databases |
| Key exclusion criteria | Patients without prognostic information in the TCGA and GEO databases |
| Date of first enrolment | 01/12/2021 |
| Date of final enrolment | 05/12/2021 |
Locations
Countries of recruitment
- China
Study participating centre
Chengdu
610041
China
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Other |
| IPD sharing plan | All data is derived from the public database online, thus the IPD sharing statement is not applicable. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 29/09/2022 | 06/01/2023 | Yes | No | |
| Results article | 24/02/2022 | 06/01/2023 | Yes | No | |
| Results article | 15/09/2022 | 06/01/2023 | Yes | No | |
| Results article | 06/04/2022 | 06/01/2023 | Yes | No | |
| Results article | 15/09/2022 | 06/01/2023 | Yes | No | |
| Results article | 03/06/2022 | 06/01/2023 | Yes | No | |
| Results article | 12/01/2022 | 06/01/2023 | Yes | No | |
| Results article | 01/03/2023 | 21/01/2025 | Yes | No | |
| Results article | 01/03/2023 | 21/01/2025 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
21/01/2025: Publication references added.
06/01/2023: Publication references added.
09/12/2021: Total final enrolment added.
01/12/2021: Trial's existence confirmed by the West China Hospital of Sichuan University Biomedical Research Ethics Committee.
