- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00186368
Microarray Analysis of Gene Expression in Prostate Tissues
July 18, 2023 updated by: Stanford University
Microarray Analysis of Gene Expression in Prostate Tissues (Translating Prostate Cancer Gene Expression Sub-types)
The purpose of this study is to investigate gene expression profiles and biologic features of prostate tissue and how they relate to prostate cancer development and growth.
Study Overview
Status
Active, not recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
2000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Stanford, California, United States, 94305
- Stanford University Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Per the original application in 1999: After obtaining informed consent (via the Tissue Bank consent), Protocol # 13873 (Continuing Review) PROTOCOL Print Date: September 22, 2010 PD: James Duane Brooks APPLICATION FORM Page 11 of 22 Review Type: Expedited Human Subjects Research Medical Stanford University Title: Microarray Analysis of Gene Expression in Prostatic Tissues (SQL 76528) Approval Period: 07/31/2010 - 06/30/2011 specimens will be collected from the Stanford University Department of Pathology (Tissue Bank) for patients treated at Stanford.
Patients will be followed up via chart or tumor registries.
Data will be used strictly for research purposes.
Gene expression arrays are done in Dr. Brook's laboratory.
Description
Inclusion Criteria:
- Patient scheduled to undergo either a biopsy or surgery for a prostate condition.
Exclusion Criteria:
- Patients without a prostate condition
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlate genotype with pathologic phenotype and clinical outcome.
Time Frame: one time
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The Tissue Bank will store all "Tissue Bank" consents.
The patients will be given a unique identifier by the tissue bank.
However, patients will need to be identified to link to clinical data and possible followup (if they have consented) via chart or tumor registries.
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one time
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: James Brooks, MD, Stanford University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 6, 1999
Primary Completion (Estimated)
December 1, 2030
Study Completion (Estimated)
December 1, 2030
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimated)
September 16, 2005
Study Record Updates
Last Update Posted (Actual)
July 19, 2023
Last Update Submitted That Met QC Criteria
July 18, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PROS0009 (Other Identifier: Stanford University)
- 13873 (Other Identifier: Stanford IRB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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