Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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This study has been withdrawn prior to enrollment.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

November 14, 2008
May 11, 2016
September 2008
September 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00801996 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Epidemiologic, Clinical and Genetic Profile of Prostate Cancer in Arab Countries
Epidemiologic, Clinical and Genetic Profile of Prostate Cancer in Arab Countries
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.
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.
Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:
Blood and tissue will be collected from individuals with prostate cancer. Only blood will be collected from normal controls.
Non-Probability Sample
  • Individuals of Arab descent from Qatari peninsula
  • Individuals from the Qatari Peninsula whose ancestors up to three generations back were natives of Qatar
Prostate Cancer
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
September 2009
September 2008   (final data collection date for primary outcome measure)

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

Both
40 Years to 80 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Qatar
 
NCT00801996
0806009874
No
Undecided
Not Provided
Weill Medical College of Cornell University
Weill Medical College of Cornell University
Not Provided
Study Director: Ronald Crystal, MD Weill Medical College of Cornell University
Weill Medical College of Cornell University
May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP