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Prostate Cancer Prospective Cohort

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00937586
Recruitment Status : Active, not recruiting
First Posted : July 13, 2009
Last Update Posted : November 25, 2022
Sponsor:
Collaborators:
Johns Hopkins University
National Cancer Institute (NCI)
Wake Forest University
Information provided by (Responsible Party):
Washington University School of Medicine

Study Description
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Brief Summary:
The overall purpose of this research is to determine if certain genes increase the chance of developing prostate cancer and once diagnosed increase the chance of the prostate cancer spreading to other parts of the body.

Condition or disease
Prostate Cancer

Detailed Description:

DNA will be isolated from each person and then studied for the presence of certain genes that may increase the chance of developing prostate cancer. Certain genes will also be studied in patients with known prostate cancer to determine if they increase the chance of cancer spreading to other parts of the body and decrease one's chance of being cured. Small differences in genes can slightly affect their ability to function. While these differences are normal, they may influence the way the cancer responds to therapy. An understanding of which genes increase (or decrease) the chance of being cured of a disease, such as prostate cancer, will improve our ability to take care of patients more effectively.

A second purpose of this study is to collect blood and cancer tissue for future studies. While the small differences in genes may be the best marker of bad cancer, it is also possible that proteins in blood or tumor may be a better marker.

Study Design
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Study Type : Observational
Actual Enrollment : 1937 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prostate Cancer Prospective Cohort
Study Start Date : May 2000
Estimated Primary Completion Date : June 2025
Estimated Study Completion Date : June 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Groups and Cohorts
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Group/Cohort
Newly diagnosed patients
Patients with newly diagnosed prostate cancer.


Outcome Measures
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Primary Outcome Measures :
  1. Ability to recognize increased risk of metastatic prostate cancer based on specific genetic polymorphisms. [ Time Frame: At the time of prostate cancer diagnosis ]

Secondary Outcome Measures :
  1. Ability to predict risk for treatment failure based on analysis of specific polymorphisms. [ Time Frame: At the time of prostate cancer diagnosis ]

Biospecimen Retention:   Samples Without DNA
Whole blood, serum, white cells, prostate tissue.

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with newly diagnosed prostate cancer are being recruited for this study from Siteman Cancer Center radiation oncology, medical oncology and urology clinics.
Criteria

Inclusion Criteria:

  • Newly diagnosed patients: 1. newly diagnosis of prostate cancer 2. untreated except for neoadjuvant systemic therapy.

Exclusion Criteria:

  • Newly diagnosed patients: 1. inability to give informed consent
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00937586


Locations
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United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Johns Hopkins University
National Cancer Institute (NCI)
Wake Forest University
Investigators
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Principal Investigator: Bettina Drake, PhD Washington University School of Medicine
More Information
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00937586    
Other Study ID Numbers: HRPO#00-0327
R01CA112028 ( U.S. NIH Grant/Contract )
First Posted: July 13, 2009    Key Record Dates
Last Update Posted: November 25, 2022
Last Verified: November 2022
Keywords provided by Washington University School of Medicine:
Metastatic Prostate Cancer
Prostate Cancer Risk Assessment
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases