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

This study is currently recruiting participants.
Verified July 2017 by Louis Kunkel, Boston Children's Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT00499317
First Posted: July 11, 2007
Last Update Posted: August 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Louis Kunkel, Boston Children's Hospital
July 9, 2007
July 11, 2007
August 1, 2017
January 15, 2007
December 31, 2020   (Final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00499317 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Genetic Study of Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
Genetic Study of Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)

Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS) is a condition with several causes of which some remain unknown. It is believed that some types of CP may be genetic or passed down (inherited) from one generation to the next.

In this study, we are collecting genetic material and medical information to try to determine if there are genetic factors may play a role in CP/CPPS. We will be collecting DNA (from Saliva) and urine from each participant. Individuals and families with CP/CPPS will be enrolled. Family members of an individual with CP/CPPS are eligible whether or not they also experience CP/CPPS symptoms.

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, whole exome sequencing and candidate gene studies. Each individual participant will be required to give a DNA sample (via Saliva) and a urine sample and answer 2 questionnaires. All samples will be stored.
Observational
Observational Model: Family-Based
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
DNA sample via saliva and urine samples will be collected and stored.
Non-Probability Sample
We are collecting individuals and families with symptoms and diagnoses of CP/CPPS and their family members (with or without symptoms) from North America (United States and Canada)
  • Chronic Prostatitis (CP)
  • Chronic Pelvic Pain Syndrome (CPPS)
  • Painful Bladder Syndrome (PBS)
  • Benign Frequency Syndrome (BFS)
  • Benign Daytime Frequency Syndrome (BDFS)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
December 31, 2021
December 31, 2020   (Final data collection date for primary outcome measure)

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 Bladder Fasciculation Syndrome (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
  • Surgery/chemotherapy in the pelvic area
  • Bacterial cause to CP/CPPS or recurrent UTI
  • Traumatic cause to CP/CPPS
Sexes Eligible for Study: Male
Child, Adult, Senior
Yes
Contact: Elicia Estrella, MS, LCGC 617-919-4552 elicia.estrella@childrens.harvard.edu
Contact: Stephanie J. Brewster, MS, LCGC 617-919-4551 stephanie.brewster@childrens.harvard.edu
United States
 
 
NCT00499317
04-11-160M
91208 ( Other Grant/Funding Number: Broad Institute )
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Yes
Plan Description: Data from individual participants will be shared with other researchers, but participants will be de-identified.
Louis Kunkel, Boston Children's Hospital
Boston Children’s Hospital
Not Provided
Principal Investigator: Louis Kunkel, PhD Boston Children’s Hospital
Boston Children’s Hospital
July 2017