Genetic Study of Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS) - Tabular View

Tracking Information

First Received Date ^ICMJE

July 9, 2007

Last Updated Date

May 22, 2008

Start Date ^ICMJE

January 2007

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00499317 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Genetic Study of Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)

Official Title ^ICMJE

Brief Summary

Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS) is a common condition with no known cure. It is estimated that every 15 seconds, a man in the USA is diagnosed with CP/CPPS. Studies have suggested that the condition may be genetic and passed down (or inherited) from one generation to the next.

In this study we are comparing different families' samples and medical information to determine which genetic factors may play a role in CP/CPPS. We will be collecting DNA and urine from each participant. Individuals and families with CP/CPPS will be enrolled. Family members are eligible with or without CP/CPPS symptoms

Detailed Description

To further describe the phenotype of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) and to correlate the phenotypic information with the genotypic findings utilizing linkage analysis and candidate gene studies. A North American cohort and a Bulgarian cohort will be recruited. Each individual participant will be required to give a DNA sample (via Saliva) and a urine sample. All samples will be stored.

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Family-Based, Prospective

Condition ^ICMJE

Chronic Prostatitis (CP)
Chronic Pelvic Pain Syndrome (CPPS)
Painful Bladder Syndrome (PBS)
Benign Frequency Syndrome (BFS)
Benign Daytime Frequency Syndrome (BDFS)

Intervention ^ICMJE

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

500

Estimated Completion Date

January 2011

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Have symptoms for at least 3 months within the preceding 6 months:
Pain in the pelvic area
Urinary frequency and/or
Urinary urgency and/or
Sexual dysfunction (erectile dysfunction)
Have CP/CPPS, IC, PBS, or BFS
Be willing to provide a saliva and urine sample
Agree to complete several brief questionnaires
Family member of someone with CP/CPPS, PBS, IC or BFS
Live in the USA or Canada

Exclusion Criteria:

Major structural/anatomical urinary tract abnormalities
Underlying inborn or congenital conditions which affect the urinary tract

Gender

Male

Ages

8 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Elicia Estrella, MS	617-919-4552	elicia.estrella@childrens.harvard.edu
Contact: Stephanie J. Brewster, MS	617-919-4551	stephanie.brewster@childrens.harvard.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00499317

Responsible Party

Jordan Dimitrakov, M.D., Ph.D., Children's Hospital, Boston

Study ID Numbers ^ICMJE

04-11-160M

Study Sponsor ^ICMJE

Children's Hospital Boston

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Jordan Dimitrakov, MD, PhD

Children's Hospital Boston

Information Provided By

Children's Hospital Boston

Verification Date

May 2008

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