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

Weill Cornell Medicine (WCM)

Status: Withdrawn

Conditions: Prostate Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT00801996

0806009874

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 40 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

0 participants in 2 patient groups

1. Prostate Cancer

Description:

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

Description:

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