- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00923221
Collection of Blood From Patients With Prostate Cancer
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.
Study Overview
Status
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
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Paula A Carter, R.N.
- Phone Number: (240) 858-3191
- Email: pcartera@mail.nih.gov
Study Contact Backup
- Name: William D Figg, Pharm.D.
- Phone Number: (240) 760-6179
- Email: figgw@mail.nih.gov
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20892
- Recruiting
- National Institutes of Health Clinical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
- 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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
---|
1/Patient samples
blood samples from patients with diagnosed prostate cancer
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
study duration
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: William D Figg, Pharm.D., National Cancer Institute (NCI)
Publications and helpful links
General 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 070100
- 07-C-0100
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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