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Collection of Blood From Patients With Prostate Cancer

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ClinicalTrials.gov Identifier: NCT00923221
Recruitment Status : Recruiting
First Posted : June 18, 2009
Last Update Posted : January 26, 2023
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Tracking Information
First Submitted Date June 17, 2009
First Posted Date June 18, 2009
Last Update Posted Date January 26, 2023
Actual Study Start Date February 28, 2007
Primary Completion Date Not Provided
Current Primary Outcome Measures
 (submitted: July 19, 2022)
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
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Collection of Blood From Patients With Prostate Cancer
Official Title Collection of Blood From Patients With Prostate Cancer
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Primary clinical
Condition
  • Cancer Of Prostate
  • Prostate Cancer
  • Prostatic Neoplasms
  • Metastatic Prostate Cancer
  • Prostate
Intervention Not Provided
Study Groups/Cohorts 1/Patient samples
blood samples from patients with diagnosed prostate cancer
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 17, 2009)
1000
Original Enrollment Same as current
Study Completion Date Not Provided
Primary Completion Date Not Provided
Eligibility 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.

Sex/Gender
Sexes Eligible for Study: Male
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
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
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00923221
Other Study ID Numbers 070100
07-C-0100
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: 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.
Current Responsible Party National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
Original Responsible Party Not Provided
Current Study Sponsor National Cancer Institute (NCI)
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: William D Figg, Pharm.D. National Cancer Institute (NCI)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date October 3, 2022