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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 6, 2024
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Study Description
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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 participants participating in NCI prostate cancer protocols.

Design:

  • Participants 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 participant signs the protocol consent form. In general, blood will be collected for genomic DNA 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).
  • Blood samples for the extraction of cell-free DNA (cfDNA) and cell-free RNA (cfRNA) may be collected at multiple timepoints for future investigations
  • Healthy controls will not be compared and no correlations will be made with prostate cancer susceptibility.
Study Design
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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

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


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


Eligibility Criteria
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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.

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): NCT00923221


Contacts
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Contact: Paula A Carter, R.N. (240) 858-3191 pcartera@mail.nih.gov
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 Recruiting
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: William D Figg, Pharm.D. National Cancer Institute (NCI)
More Information
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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 6, 2024
Last Verified: April 5, 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: .All IPD recorded in the medical record will be shared with intramural investigators upon request. @@@@@@In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Clinical data available during the study and indefinitely.@@@@@@Genomic data are available once genomic data are uploaded per protocol GDS plan for as long as database is active.
Access Criteria: Clinical data will be made available via subscription to BTRIS and with the permission of the study PI.@@@@@@Genomic data are made available via dbGaP through requests to the data custodians.

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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
 Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases