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Collection of Blood From Patients With Prostate Cancer

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00923221
Recruitment Status : Recruiting
First Posted : June 18, 2009
Last Update Posted : May 20, 2022
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Brief Summary:

Background:

  • It is not fully understood why prostate cancer in some men becomes androgen-independent (no longer responds to anti-androgen medication), but genetics likely plays an important role.
  • Genes contain the hereditary information that is passed down from parents to children. Although everyone has the same set of genes, individuals can have different forms of the same gene.
  • Differences in genes may explain, at least in part, why some people develop a more aggressive form of prostate cancer than others.

Objectives:

-To obtain blood samples from patients with prostate cancer to try to identify gene differences associated with progression to the androgen independent state.

Eligibility:

-All patients participating in NCI prostate cancer protocols.

Design:

  • Patients with prostate cancer are evaluated in the NCI s Medical Oncology Clinic.
  • Blood samples are collected at the initial visit or at follow-up visits.
  • DNA (genetic material) and white blood cells are extracted from these samples to be used for genotyping and establishment of cell lines.
  • Gene variations are correlated with prostate cancer prognosis and prognostic indicators.

Condition or disease
Cancer Of Prostate Prostate Cancer Prostatic Neoplasms Metastatic Prostate Cancer Prostate

Detailed Description:

Objectives:

-To obtain blood samples from patients with prostate cancer for genotyping analyses.

Eligibility:

- All patients seen in the NCI prostate cancer clinic are eligible.

Design:

Patients with a prior diagnosis of prostate cancer will be evaluated in the GMB Clinic, NCI.

Blood samples will be collected after the patient signs the protocol consent form. In general, blood will be collected one time for this study. Extra samples may be requested if the original sample was not enough. The additional sample can range from one to two tubes of blood (approximately 2-3 teaspoons total). Genomic DNA and white blood cells will each be extracted from these samples to be utilized for genotyping and establishment of individual cell lines.

Genetic variance will be correlated with prostate cancer prognosis (i.e. time from diagnosis to death) and prognostic indicators (i.e. histological tumor grade).

Healthy controls will not be compared and no correlations will be made with prostate cancer susceptibility.

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Collection of Blood From Patients With Prostate Cancer
Actual Study Start Date : February 28, 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Group/Cohort
1/Patient samples
blood samples from patients with diagnosed prostate cancer



Primary Outcome Measures :
  1. Acquisition and longitudinal analysis of genomic DNA from patients with prostate cancer [ Time Frame: Study duration ]
    Acquisition and longitudinal analysis of genomic DNA from patients with prostate cancer to aid in understanding the mechanisms of prostate carcinogenesis and progression



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary clinical
Criteria
  • INCLUSION CRITERIA:

Patients 18 years of age and older are eligible.

Patients with a diagnosis of prostate cancer are eligible.

EXCLUSION CRITERIA:

Children are not eligible.


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): NCT00923221


Contacts
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Contact: William D Figg, Pharm.D. (240) 760-6179 figgw@mail.nih.gov

Locations
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United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office    (888) NCI-1937      
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: William D Figg, Pharm.D. National Cancer Institute (NCI)
Additional Information:
Publications:
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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00923221    
Obsolete Identifiers: NCT00899249
Other Study ID Numbers: 070100
07-C-0100
First Posted: June 18, 2009    Key Record Dates
Last Update Posted: May 20, 2022
Last Verified: August 31, 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Genetic
Prostatic Neoplasms
Genotyping
Venipuncture
Polymorphism
Natural History
Prostate Cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases