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Home > "G" Clinical Trials Conditions > Genetic Analysis of Hereditary Prostate Cancer  Genetic Analysis of Hereditary Prostate Cancer
Genetic Analysis of Hereditary Prostate Cancer
For Condition: Hereditary Neoplastic Syndrome,Prostatic Neoplasm
Status: Recruiting
Sponsor(s): National Human Genome Research Institute (NHGRI) ,
Synopsis: The purposes of this study are to determine if prostate cancer is inherited in some families, to find the gene or genes responsible for hereditary prostate cancer, and to understand how the gene(s) cause prostate cancer. Participants will be enrolled through institutions collaborating in the National Human Genome Research Institute/Johns Hopkins University multi-center study to identify the gene for hereditary prostate cancer. Eligibility for this study is based on the following family characteristics: 1. a cluster of three or more first degree relatives, such as a father and two sons or three brothers, or 2. prostate cancer in each of three generations in either the patient's mother's or father's family 3. two first or second degree relatives affected at an early age (55 years or younger). Participants are not seen at the National Institutes of Health and have no contact with NHGRI researchers. The collaborating institutions - Johns Hopkins University, Baltimore, Maryland; University of Maryland; Marshfield Medical Research Foundation, Marshfield, Wisconsin; Mayo Clinic, Rochester, Minnesota; Howard University, Washington, D.C.; Seattle Prostate Consortium, Seattle, Washington; Tampere University, Tampere, Finland; University of Michigan, Ann Arbor, Michigan; University of Lund, Lund Sweden are responsible for the clinical management of participants. As part of this study, blood samples from patients and family members in the NHGRI/JHU study are collected and sent to NHGRI for laboratory genetic testing and statistics analyses. For this procedure, participants are required to answer questions by telephone about their personal and family medical history, provide a blood sample for genetic testing, and complete a written questionnaire. Some family members may also be asked to provide a blood sample and answer personal and family health questions by phone. In addition, blood samples may be requested for chromosome analysis in families with one or more members affected by conditions such as developmental delay, mental retardation, a birth defect or multiple miscarriages. Chromosomes are hereditary units made up of genes. If a variation, or rearrangement, of the normal chromosome configuration is found, it might shorten the search for the hereditary prostate cancer gene.
Details: Molecular approaches to the understanding of human neoplastic disease have revealed that multiple genetic alterations are an essential component of tumorigenesis. Both germline and somatic genetic alterations can be involved in the malignant transformation of normal cells. Identification of the genes involved in neoplastic transformation has been approached through the molecular analysis of sporadic cancers and the genetic study of families with an inherited predisposition for cancer. The interplay of these two approaches has led to the characterization of genes such as the retinoblastoma (Rb) gene, the p53 gene and the adenomatous polyposis coli (APC) gene that are all involved in the development of both hereditary and non-hereditary forms of cancer. Inherited mutations in such genes predispose affected families to hereditary cancer syndromes, affording an opportunity to identify lesions that also cause the more common sporadic cancers. Prostate cancer is the most common cancer diagnosed (1999 estimate 179,300 cases) and the second leading cause of cancer mortality (1999 estimate 37,000 deaths) in men in the United States. Family history is the single strongest risk factor currently known for prostate cancer. This raises the possibility that heritable genetic factors may be involved in the development of this disease in a subset of men. The genetic contribution to diseases of complex origin such as cancer is often most salient in families of early onset cases. Therefore, prostate cancer inheritance following a simple Mendelian pattern, may be identified in the families of probands with early-onset cases.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Enrollment in this study will be limited to affected individuals from families that meet the following criteria for Hereditary Prostate Cancer: 1. A cluster of 3 or more first degree relatives, such as a father and 2 sons or 3 brothers, or; 2. The occurrence of prostate cancer in each of 3 generations in either the proband's paternal or maternal lineages, or; 3. Two first or second-degree relatives affected at an early age (age 55 years or younger).
Total Enrollment: 6500
Location and Contact Information:
National Human Genome Research Institute (NHGRI) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 950158; 95-HG-0158
Study Start Date: July 14, 1995
Record last reviewed: June 23, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001469
Other Prostatic Neoplasm Studies:
1. Treatment of Prostate Cancer with Docetaxel Alone and in Combination with Thalidomide
2. A Randomized Phase II Study of Oral Thalidomide in Patients with Hormone-Refractory Prostate Cancer
3. A Randomized Phase II Study of High Dose Ketoconazole Plus Alendronate Versus High Dose Ketoconazole in Patients with Androgen Independent Metastatic Prostate Cancer
4. A Phase II Trial of Leuprolide + Flutamide + Suramin in Untreated Poor Prognosis Prostate Carcinoma
5. Genetic Analysis of Hereditary Prostate Cancer
Related Studies:
Other Prostatic Neoplasm Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Genetic Analysis of Hereditary Prostate Cancer
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