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

NCT00801996 | Withdrawn

• 1 other identifier: 0806009874
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

prostate cancer; genetics

Outcome Measures

Primary Outcomes (1)

• Identification of single nucleotide polymorphisms (SNPs) in genes associated with prostate cancer in the Qatari population.

  3 years

Secondary Outcomes (1)

• 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

Study Arms (2)

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 Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may not qualify if:

• All study subjects should be able to provide informed consent
• Individuals of Arab descent from Qatari peninsula without any personal or family history of prostate cancer
• Individuals with family history of prostate cancer
• Individuals not deemed in good overall health by the investigator will not be accepted into the study
• 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
• Patient refuses consent

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medical College - Qatar

Doha, Qatar, Qatar

Location

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Ronald Crystal, MD

  Weill Medical College of Cornell University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2008
• First Posted: December 4, 2008
• Study Start: September 1, 2008
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2009
• Last Updated: May 13, 2016

Record last verified: 2016-05

Locations

QA (1)