Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1000 participants
OBSERVATIONAL
2007-02-28
Brief Summary
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* 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.
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Detailed Description
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-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.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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1/Participant samples
Blood samples from participants with diagnosed prostate cancer
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Individuals with a diagnosis of prostate cancer are eligible.
Exclusion Criteria
18 Years
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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William D Figg, Pharm.D.
Role: PRINCIPAL_INVESTIGATOR
National Cancer Institute (NCI)
Locations
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National Institutes of Health Clinical Center
Bethesda, Maryland, United States
Countries
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Central Contacts
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References
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Eisenberger MA, Blumenstein BA, Crawford ED, Miller G, McLeod DG, Loehrer PJ, Wilding G, Sears K, Culkin DJ, Thompson IM Jr, Bueschen AJ, Lowe BA. Bilateral orchiectomy with or without flutamide for metastatic prostate cancer. N Engl J Med. 1998 Oct 8;339(15):1036-42. doi: 10.1056/NEJM199810083391504.
Eisenberger MA, Simon R, O'Dwyer PJ, Wittes RE, Friedman MA. A reevaluation of nonhormonal cytotoxic chemotherapy in the treatment of prostatic carcinoma. J Clin Oncol. 1985 Jun;3(6):827-41. doi: 10.1200/JCO.1985.3.6.827.
Ruijter E, van de Kaa C, Miller G, Ruiter D, Debruyne F, Schalken J. Molecular genetics and epidemiology of prostate carcinoma. Endocr Rev. 1999 Feb;20(1):22-45. doi: 10.1210/edrv.20.1.0356. No abstract available.
Related Links
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NIH Clinical Center Detailed Web Page
Other Identifiers
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07-C-0100
Identifier Type: -
Identifier Source: secondary_id
070100
Identifier Type: -
Identifier Source: org_study_id
NCT00899249
Identifier Type: -
Identifier Source: nct_alias
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