Study of Blood and Tumor Samples From Men With an Inherited Risk of Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT00959023|
Recruitment Status : Unknown
Verified August 2009 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : August 14, 2009
Last Update Posted : August 26, 2013
RATIONALE: Studying samples of blood and tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify genes related to cancer.
PURPOSE: This clinical trial is studying blood and tumor samples from men with an inherited risk of prostate cancer.
|Condition or disease||Intervention/treatment|
|Prostate Cancer||Other: laboratory biomarker analysis Other: medical chart review Other: questionnaire administration|
- To find genes that predispose to prostate cancer (using genetic linkage and other molecular biology techniques).
- To determine if genes that predispose to prostate cancer are associated with disease and treatment parameters.
- To determine if genes that predispose to prostate cancer are associated with environmental factors.
- To estimate the percentage of prostate cancer patients who have a positive family history of the disease.
- To estimate the relative risk of developing prostate cancer in a currently unaffected member of a prostate cancer family.
- To ascertain whether relatives of prostate cancer patients are at increased risk of developing cancers other than prostate cancer.
- To build up a large blood and tumor (both fresh and preserved) bank from patients with prostate cancer to identify prostate cancer predisposition gene(s), determine the prevalence and penetrance of prostate cancer predisposition genes in prostate cancer patients, correlate changes in prostate cancer predisposition gene(s) with disease and treatment parameters by matching with clinical data from clinical databases already held as part of the medical record on these patients, and correlate changes in prostate cancer predisposition gene(s) with environmental factors collected by questionnaire from these patients.
- To use the blood and tumor bank for marker studies (DNA, RNA, serum, plasma, protein, and other molecules) to define the role of these markers in disease prediction and progression.
- To develop microarrays from prostate cancers to determine their genetic profile and correlate this with prostate cancer genetic predisposition genes.
- To collect tissue from other unaffected and affected members of the family in cases where a genetic alteration is found, in order to ascertain whether this alteration is associated with disease risk.
- To collect tissue samples from unaffected family members who show an interest in taking part in the study.
OUTLINE: Patients are assessed by a family history and epidemiology questionnaire and undergo a medical record review.
Patients and relatives with prostate cancer may undergo blood sample collection for genetic analysis of prostate cancer predisposition genes and measurement of markers of associations with genetic changes associated with prostate cancer. Blood and tumor samples are stored for future studies.
|Study Type :||Observational|
|Estimated Enrollment :||21000 participants|
|Official Title:||UK Genetic Prostate Cancer Study|
|Study Start Date :||June 1993|
- Prostate cancer (PC) predisposition (PCP) genes
- Association of PCP genes with disease and treatment parameters
- Association of PCP with environmental factors
- Family history of PC
- Relative risk of developing PC
- Increased risk relatives of PC patients are to develop cancers other than PC
- Markers of PC that are associated with PCP genes
- Specific tumor genetic profile correlated with PCP genes
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00959023
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|Principal Investigator:||Rosalind Eeles, PhD, FRCR, FRCP, FMed Sci||Royal Marsden NHS Foundation Trust|