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Microarray Analysis of Gene Expression in Prostate Tissues

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT00186368
First received: September 13, 2005
Last updated: February 21, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition
Prostate Cancer

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Microarray Analysis of Gene Expression in Prostate Tissues (Translating Prostate Cancer Gene Expression Sub-types)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Correlate genotype with pathologic phenotype and clinical outcome. [ Time Frame: one time ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 2000
Study Start Date: April 1999
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
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.

Criteria

Inclusion Criteria:

- Patient scheduled to undergo either a biopsy or surgery for a prostate condition.

Exclusion Criteria:

- Patients without a prostate condition

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00186368

Locations
United States, California
Stanford University Cancer Center
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: James Brooks, MD Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT00186368     History of Changes
Other Study ID Numbers: PROS0009, PROS0009, 76528
Study First Received: September 13, 2005
Last Updated: February 21, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
Prostate cancer
Gene expression
tumor markers
microarray analysis

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on June 18, 2013