- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03789253
Identify Genes/Pathways Responsible for Progression From Low Risk to Higher Risk Prostate Cancer
Identify Genes/Pathways Responsible for Progression From Low Risk to Higher Risk Prostate Cancer-A New Strategy for Prostate Cancer Prevention
Study Overview
Status
Conditions
Detailed Description
At the Department of Urology, NTUH, we have established a largest Chinese AS/WW cohort, which were prospectively collected since 2013. There were already 280 AS and 100 WW patients. Most AS patients have undergone serial prostate re-biopsies every 1 to 2 years, which is actually our cutting edge in the field. 87 men had at least twice biopsies at our hospital (mean interval 15 months). 26 of them showed pathological progression (Group As) who have been treated aggressively. The other 61 men had no progression even after multiple biopsies (Group Bs). So, we may compare the genetic changes in each subject in Group A to reveal genetic changes responsible for progression. We can also compare baseline expressions between Group A and B to predict progression. We also can correlate genetic alterations in Group A with cancer phenotypes and short-term post-treatment outcomes.
Here are the four Specific Aims:
Aim-1. To investigate the role of known genes or pathways in mediating progression from low risk to higher risk by using serial biopsy paraffin embedded tissue blocks from our AS patients. These known genes/pathways are selected from published reports, which are found to be related to progression from low to higher grade PC, such as Ki-67, PTEN loss, and chromosome 8 alterations.
Aim-2. There was only one cDNA microarray gene bank (GSE37199) published in the literature (Lancet Oncol. 2012; 13:1114) that was associated with differential expression between AS and mCRPC cohorts. We will proceed with the Gene Set Enrichment Analysis (GSEA) to identify more potential genes or pathways that have NOT been specifically demonstrated relating to AS progression. These new genes or pathways will then be studied in Aim-1.
Aim-3. We will perform global cDNA microarray sing non-cancer part of the serial biopsy paraffin tissue blocks from our AS cohort, followed by GSEA to reveal differential gene expression between Group A and B patients. Hopefully we can identify genes/pathways that are related to progression of low risk or latent PC in Taiwanese.
Aim-4. To conduct multivariate analyses considering not only key genetic alterations but also multiple clinicopathological parameters to build up a model predicting progression from low to higher risk PC.
In fact, the only one published study (Lancet Oncol. 2012;13:1114) was to reveal differential cDNA expression in blood cells between AS and mCRPC cohorts, but not between progressive and non-progressive patients. Therefore, the study design was defective because the obtained differential expression may not reflect what really happened in low risk cancer progression. To our knowledge, there has been no differential genetic expression study or the GSEA study for AS cohort. In addition, we have the largest Taiwanese/Chinese cohort on AS/WW and abundant serial biopsy specimens. In summary, our study which focuses on genomic research on AS cohort is a new strategy to prevent clinical PC and is of high novelty and clinical implications.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Yeong-Shiau Pu, PhD
- Phone Number: 65950 886-2-23123456
- Email: yspu@ntu.edu.tw
Study Contact Backup
- Name: Chung-Hsin Chen, PhD
- Phone Number: 65242 886-2-23123456
- Email: mufasachen@gmail.com
Study Locations
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Taipei, Taiwan, 10002
- Recruiting
- National Taiwan University
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Contact:
- Yeong-Shiau Pu, PhD
- Phone Number: 65950 886-2-23123456
- Email: yspu@ntu.edu.tw
-
Contact:
- Chung-Hsin Chen, PhD
- Phone Number: 65242 886-2-23123456
- Email: mufasachen@gmail.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Historically or cytologically confirmed adenocarcinoma of prostate.
- Have or ever received active Surveillance as the main conservative management at NTUH (National Taiwan University Hospital).
- Have or will receive prostate biopsy to confirm tumor progression after the diagnosis of prostate cancer.
Exclusion Criteria:
- Have received systemic chemotherapy, pelvic radiotherapy or androgen deprivation therapy (ADT) before the obtainment of pathological specimen from prostate operation or biopsy.
- Subjects who disagree with signing the informed consent.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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AS cohort with progression
AS cohort with tumor progression
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AS cohort without progression
AS cohort without tumor progression
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gene expression
Time Frame: 3 years
|
Using GESA analysis
|
3 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Yeong-Shiau Pu, PhD, National Taiwan University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201712093RINB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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