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

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

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

Conditions
-----------------
Prostate Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1. Prostate Cancer<br>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 | |
| 2. Normal Healthy Controls<br>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 | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of single nucleotide polymorphisms (SNPs) in genes associated with prostate cancer in the Qatari population. |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prostate cancer, genetics