We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
  Purpose

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.


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

Study Type: Observational
Study Design: Observational Model: Family-Based
Time Perspective: Prospective
Official Title: Genetic Study of Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)

Resource links provided by NLM:


Further study details as provided by Louis Kunkel, Boston Children's Hospital:

Biospecimen Retention:   Samples With DNA
DNA sample via saliva and urine samples will be collected and stored.

Estimated Enrollment: 500
Actual Study Start Date: January 15, 2007
Estimated Study Completion Date: December 31, 2021
Estimated Primary Completion Date: December 31, 2020 (Final data collection date for primary outcome measure)
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, 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.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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)
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00499317


Contacts
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

Locations
United States, Massachusetts
Children's Hospital, Boston Recruiting
Boston, Massachusetts, United States, 02115
Contact: Elicia Estrella, MS, LCGC    617-919-4552    elicia.estrella@childrens.harvard.edu   
Contact: Stephanie Brewster, MS, LCGC    617-919-4551    Stephanie.Brewster@childrens.harvard.edu   
Principal Investigator: Louis M Kunkel, PhD         
Sponsors and Collaborators
Boston Children’s Hospital
Investigators
Principal Investigator: Louis Kunkel, PhD Boston Children’s Hospital
  More Information

Publications:
Responsible Party: Louis Kunkel, Professor of Genetics and Pediatrics, Harvard Medical School, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT00499317     History of Changes
Other Study ID Numbers: 04-11-160M
91208 ( Other Grant/Funding Number: Broad Institute )
First Submitted: July 9, 2007
First Posted: July 11, 2007
Last Update Posted: August 1, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data from individual participants will be shared with other researchers, but participants will be de-identified.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Louis Kunkel, Boston Children's Hospital:
Urgency
Frequency
Pelvic pain
Sexual dysfunction
Erectile dysfunction
Painful intercourse

Additional relevant MeSH terms:
Syndrome
Somatoform Disorders
Pelvic Pain
Prostatitis
Cystitis, Interstitial
Chronic Disease
Disease
Pathologic Processes
Mental Disorders
Pain
Neurologic Manifestations
Signs and Symptoms
Prostatic Diseases
Genital Diseases, Male
Cystitis
Urinary Bladder Diseases
Urologic Diseases
Disease Attributes