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

This study has been withdrawn prior to enrollment.
(Closed by Investigator)
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00801996
First received: November 14, 2008
Last updated: May 11, 2016
Last verified: May 2016
  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

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

Resource links provided by NLM:


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

Enrollment: 0
Study Start Date: September 2008
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: September 2008 (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

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

Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Qatar
Weill Cornell Medical College - Qatar
Doha, Qatar
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Study Director: Ronald Crystal, MD Weill Medical College of Cornell University
  More Information

Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00801996     History of Changes
Other Study ID Numbers: 0806009874 
Study First Received: November 14, 2008
Last Updated: May 11, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Weill Medical College of Cornell University:
prostate cancer
genetics

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on August 25, 2016