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

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.
 
ClinicalTrials.gov Identifier: NCT00499317
Recruitment Status : Recruiting
First Posted : July 11, 2007
Last Update Posted : June 10, 2022
Sponsor:
Information provided by (Responsible Party):
Catherine Brownstein, Boston Children's Hospital

Brief Summary:

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 genetic factors play a role in CP/CPPS. We will be collecting DNA (from Blood/Saliva sample) and urine from each participant. Bladder tissue from affected individuals will also be collected. 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 or disease
Chronic Prostatitis (CP) Chronic Pelvic Pain Syndrome (CPPS) Painful Bladder Syndrome (PBS) Benign Frequency Syndrome (BFS) Interstitial Cystitis

Detailed Description:
We would like to determine if chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) has a genetic cause. We will be attempting to further describe the symptoms of CP/CPPS and to correlate them with changes in your genes. We will use several types of genetic testing; linkage analysis, whole exome sequencing and candidate gene studies. Each individual participant will be required to give a DNA sample (via Blood/Saliva), a urine sample and answer questionnaires. Affected participants will also be asked to provide a bladder sample from a clinical biopsy. All samples will be stored. Travel to Boston NOT required.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Family-Based
Time Perspective: Prospective
Official Title: Genetic Study of Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
Actual Study Start Date : January 15, 2007
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pelvic Pain




Biospecimen Retention:   Samples With DNA
DNA sample via blood/saliva, bladder tissue and urine samples will be collected and stored.


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.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
We are collecting individuals with a diagnoses of CP/CPPS and their family members (with or without symptoms) from North America (United States and Canada). Preference is given to families with multiple affected individuals (males or females with IC/BPS/CPPS).
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, Interstitial Cystitis (IC), Bladder Pain Syndrome BPS, or Bladder Fasciculation Syndrome (BFS)
  • Be willing to provide a blood/saliva, bladder tissue (from previous biopsy) and urine sample
  • Agree to complete several brief questionnaires
  • Family member of someone with CP/CPPS, BPS, 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 Urinary tract infections (UTI)
  • Traumatic cause to CP/CPPS

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
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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
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United States, Massachusetts
Boston Children's Hospital (BCH) 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: Catherine Brownstein, PhD         
Sponsors and Collaborators
Boston Children's Hospital
Investigators
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Principal Investigator: Catherine Brownstein, PhD Boston Children's Hospital
Publications of Results:
Other Publications:
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Responsible Party: Catherine Brownstein, Assoc. Professor of Genetics and Pediatrics, Harvard Medical School, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT00499317    
Other Study ID Numbers: 04-11-160M
91208 ( Other Grant/Funding Number: Broad Institute )
First Posted: July 11, 2007    Key Record Dates
Last Update Posted: June 10, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data from individual participants may be shared with other researchers. Other research studies will be approved by our internal review board and participants samples and data will be de-identified.
Supporting Materials: Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: We will store study information and samples indefinitely and may share this information with future collaborators. All shared samples and data will be de-identified.
Access Criteria: De-identified data may be shared with other CP/CPPS researchers or other BCH researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Catherine Brownstein, Boston Children's Hospital:
Urgency
Frequency
Pelvic pain
Sexual dysfunction
Erectile dysfunction
Painful intercourse
Additional relevant MeSH terms:
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Cystitis
Cystitis, Interstitial
Prostatitis
Syndrome
Pelvic Pain
Chronic Disease
Somatoform Disorders
Disease
Pathologic Processes
Mental Disorders
Pain
Neurologic Manifestations
Urinary Bladder Diseases
Urologic Diseases
Prostatic Diseases
Disease Attributes