Prostate CancerProstateCANCT00801996
Epidemiologic, Clinical and Genetic Profile of Prostate Cancer in Arab Countries
An observational study of Prostate Cancer, run by Weill Medical College of Cornell University at 1 site in Qatar.
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. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- How many people
- 0 participants
- Where
- 1 siteQatar
- Study dates
- Sep 2008to Sep 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
- 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
Who cannot join
- Individuals with family history of prostate cancer
- Individuals not deemed in good overall health by the investigator will not be accepted into the study
- Patient refuses consent
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, genetics
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of single nucleotide polymorphisms (SNPs) in genes associated with prostate cancer in the Qatari population.
Measured: 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)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2008 (estimated)
- Study startSep 2008
- Primary completionSep 2008 (estimated)
- Study completionSep 2009 (estimated)
Why it stopped: Closed by Investigator
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ronald Crystal, MD, Study director, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00801996
- Sponsor's protocol ID
- 0806009874
- Acronym
- ProstateCA
- Status last verified
- May 2016
- First submitted
- 14 Nov 2008
- Last updated
- 13 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiologic, Clinical and Genetic Profile of Prostate Cancer in Arab Countries
- ClinicalTrials.gov ID
- NCT00801996
- Acronym / sponsor ID
- ProstateCA / 0806009874
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, genetics
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Closed by Investigator
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Sep 2008 (estimated)
- Study completion
- Sep 2009 (estimated)
- First posted
- 4 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (8 listed)
- 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
- All study subjects should be able to provide informed consent
- Males ages 40 years or older
Key exclusion criteria (3 listed)
- Individuals with family history of prostate cancer
- Individuals not deemed in good overall health by the investigator will not be accepted into the study
- Patient refuses consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identification of single nucleotide polymorphisms (SNPs) in genes associated with prostate cancer in the Qatari population.
Time frame: 3 years
1 secondary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald Crystal, MD study director
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Weill Medical College of Cornell University at 1 site in Qatar.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Qatar. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of single nucleotide polymorphisms (SNPs) in genes associated with prostate cancer in the Qatari population. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2016.