Prostate Cancer - Qatar - Full Text View

Sponsored by:	Weill Medical College of Cornell University
Information provided by:	Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:	NCT00801996

Purpose

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.

Condition
Prostate Cancer

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Cross-Sectional
Official Title:	Epidemiologic, Clinical and Genetic Profile of Prostate Cancer in Arab Countries

Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:

Identification of single nucleotide polymorphisms (SNPs) in genes associated with prostate cancer in the Qatari population. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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) [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

Blood and tissue will be collected from individuals with prostate cancer. Only blood will be collected from normal controls.

Estimated Enrollment:	700
Study Start Date:	November 2008
Estimated Study Completion Date:	November 2011
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts
1. Prostate Cancer 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 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

Groups/Cohorts

1. Prostate Cancer

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

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

Eligibility

Ages Eligible for Study:	40 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00801996

Locations

Qatar
Weill Cornell Medical College - Qatar	Recruiting
Doha, Qatar
Contact: Amani Ma'ayah, MS, Pharm. 011-974-492-8405 asm2004@qatar-med.cornell.edu
Principal Investigator: Lotfi Chouchange, PhD

Sponsors and Collaborators

Weill Medical College of Cornell University

More Information

Responsible Party:	Weill Cornell Medical College ( Dr. Alvin Mushlin )
Study ID Numbers:	0806009874
Study First Received:	November 14, 2008
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00801996
Health Authority:	United States: Institutional Review Board; Qatar: Study Coordinator, WCMC - Qatar

Keywords provided by Weill Medical College of Cornell University:

prostate cancer
genetics

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009