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

Prostate Cancer Clinical Trial

— ProstateCA  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00801996
• Other study ID #: 0806009874
• Status: Withdrawn
• Phase: N/A
• First received: November 14, 2008
• Last updated: May 11, 2016
• Start date: September 2008
• Est. completion date: September 2009

Study information

• Verified date: May 2016
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2009
• Est. primary completion date: September 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
Qatar	Weill Cornell Medical College - Qatar	Doha

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

Qatar, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of single nucleotide polymorphisms (SNPs) in genes associated with prostate cancer in the Qatari population.		3 years	No
Secondary	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	No