Collection of Blood From Patients With Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cancer Of Prostate, Prostate Cancer, Prostatic Neoplasms, Metastatic Prostate Cancer. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Acquisition and longitudinal analysis of genomic DNA, cfDNA, and cfRNA from participants with prostate cancer [Time frame: study duration]
Eligibility criteria
- INCLUSION CRITERIA:
Individuals 18 years of age and older are eligible.
Individuals with a diagnosis of prostate cancer are eligible.
Exclusion criteria
Children are not eligible.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- National Institutes of Health Clinical Center — Bethesda
Publications
- 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. PMID 9761805
- 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. PMID 2409240
- 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. PMID 10047972
Identifiers
NCT: NCT00923221 · 070100 · 07-C-0100