Clinical trial NCT00801996: Epidemiologic, Clinical and Genetic Profile of Prostate Cancer in Arab Countries
Official title: Epidemiologic, Clinical and Genetic Profile of Prostate Cancer in Arab Countries
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Prostate Cancer
Keywords: prostate cancer
genetics
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2008-12-04
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Individuals of Arab descent from Qatari peninsula
* Individuals from the Qatari Peninsula whose ancestors up to three generations back were natives of Qatar

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.

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

Primary outcomes:
measure: Identification of single nucleotide polymorphisms (SNPs) in genes associated with prostate cancer in the Qatari population.
timeFrame: 3 years
Secondary outcomes:
measure: 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)
timeFrame: 3 years
Other outcomes:
Locations:
city: Doha
country: Qatar
facility: Weill Cornell Medical College - Qatar
Study officials:
affiliation: Weill Medical College of Cornell University
name: Ronald Crystal, MD
role: STUDY_DIRECTOR
References: