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Study of Blood and Tumor Samples From Men With an Inherited Risk of Prostate Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00959023
First received: August 13, 2009
Last updated: January 11, 2013
Last verified: August 2009
History of Changes
  Purpose

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 Intervention
Prostate Cancer
 Other: laboratory biomarker analysis
Other: medical chart review
Other: questionnaire administration

Study Type: Observational
Official Title: UK Genetic Prostate Cancer Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Prostate cancer (PC) predisposition (PCP) genes [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Association of PCP genes with disease and treatment parameters [ Designated as safety issue: No ]
  • Association of PCP with environmental factors [ Designated as safety issue: No ]
  • Family history of PC [ Designated as safety issue: No ]
  • Relative risk of developing PC [ Designated as safety issue: No ]
  • Increased risk relatives of PC patients are to develop cancers other than PC [ Designated as safety issue: No ]
  • Markers of PC that are associated with PCP genes [ Designated as safety issue: No ]
  • Specific tumor genetic profile correlated with PCP genes [ Designated as safety issue: No ]

Estimated Enrollment: 21000
Study Start Date: June 1993
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Meets 1 of the following criteria:

    • Diagnosis of prostate cancer meeting any of the following criteria:

      • Attending prostate clinics at The Royal Marsden NHS Foundation Trust

        • Any age at diagnosis

      • Not attending prostate clinics at The Royal Marsden NHS Foundation Trust, meeting 1 of the following criteria:

        • No older than 60 years at diagnosis
        • Diagnosis in two relatives where one is ≤ 65 years at diagnosis
        • At any age in a cluster with 3 or more cases
    • Any unaffected male relatives of men who are already taking part in the study

PATIENT CHARACTERISTICS:

  • Able to understand the information sheet and give informed consent
  • No man who is too ill to take part

PRIOR CONCURRENT THERAPY:

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00959023

  Show 135 Study Locations
Sponsors and Collaborators
Institute of Cancer Research, United Kingdom
Investigators
Principal Investigator: Rosalind Eeles, PhD, FRCR, FRCP, FMed Sci Royal Marsden NHS Foundation Trust
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00959023     History of Changes
Other Study ID Numbers: CDR0000636371, ICR-UKGPCS, EU-20909
Study First Received: August 13, 2009
Last Updated: January 11, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
 stage III prostate cancer
stage IV prostate cancer
recurrent prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 16, 2013