Epidemiologic, Clinical and Genetic Profile of Prostate Cancer in Arab Countries

N/AWithdrawnNCT00801996

Weill Medical College of Cornell University

Overview

This protocol is designed to collect a small amount of blood and tissue from individuals with prostate cancer for extraction of DNA (genetic material) for the study of the genetic basis of prostate cancer. The study population will include individuals with known prostate cancer and controls without prostate cancer. The study will be conducted in Doha, Qatar at the Hamad Medical Corporation and Weill Cornell Medical College (Qatar). Individuals in the study population will be of Arab descent from Qatar. In this protocol, researchers will survey epidemiologic factors and medical records of patients with prostate cancer in order to study the clinical characteristics of these individuals. The researchers will collect blood and tissue samples to evaluate the genetic characteristics of individuals with prostate cancer. The researchers will also collect blood samples of individuals without prostate cancer to serve as a control. The goal will be to identify genes that are associated with prostate cancer and gene profiles that are associated with differing prognoses in individuals who have prostate cancer.

The study population will include individuals with known prostate cancer and controls without prostate cancer. Individuals in the study population will be of Arab descent from Qatar. In this protocol, researchers will survey epidemiologic factors and medical records of patients with prostate cancer in order to study the clinical characteristics of these individuals. The researchers will collect blood and tissue samples to evaluate the genetic characteristics of individuals with prostate cancer. The researchers will also collect blood samples of individuals without prostate cancer to serve as a control. The goal will be to identify genes that are associated with prostate cancer and gene profiles that are associated with differing prognoses in individuals who have prostate cancer.

Study Type

OBSERVATIONAL

Conditions

Prostate Cancer

Eligibility

Medical Language ↔ Plain English

Inclusion/Exclusion Criteria for Normal Cohort Inclusion Criteria: * All study subjects should be able to provide informed consent * Males or females ages 40 years or older (see section A8 for the rationale for the inclusion of females) * Individuals of Arab descent from Qatari peninsula without any personal or family history of prostate cancer Exclusion Criteria: * Individuals with family history of prostate cancer * Individuals not deemed in good overall health by the investigator will not be accepted into the study Inclusion/Exclusion Criteria for Prostate Cohort Inclusion Criteria: * All study subjects should be able to provide informed consent * Males ages 40 years or older * Individuals from the Qatari Peninsula whose ancestors up to three generations back were natives of Qatar. * Individuals undergoing Trans Rectal Ultrasound (TRUS) biopsy as dictated by their standard clinical care * Ultrasound OR digital rectal examination consistent with prostate disease OR A level of PSA (Prostatic Specific Antigen) greater than 3.0 Exclusion Criteria: • Patient refuses consent

Outcomes

Primary Outcomes

Identification of single nucleotide polymorphisms (SNPs) in genes associated with prostate cancer in the Qatari population.

Time frame: 3 years

Secondary Outcomes

Use of gene expression profiles to develop molecular signatures of prostate cancer that are associated with clinical/pathological phenotypes (e.g., tumor grade, histology, disease stage, responsiveness to therapy)