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

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ClinicalTrials.gov Identifier: NCT00499317
Recruitment Status : Recruiting
First Posted : July 11, 2007
Last Update Posted : October 9, 2018
Sponsor:
Information provided by (Responsible Party):
Louis Kunkel, 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 there are genetic factors may play a role in CP/CPPS. We will be collecting DNA (from a Saliva sample) 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 or disease
Chronic Prostatitis (CP) Chronic Pelvic Pain Syndrome (CPPS) Painful Bladder Syndrome (PBS) Benign Frequency Syndrome (BFS) Benign Daytime Frequency Syndrome (BDFS)

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 Saliva), a urine sample and answer 2 questionnaires. All samples will be stored. Travel to Boston NOT required.

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, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pelvic Pain




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


Information from the National Library of Medicine

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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/PBS).
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

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

Publications of Results:
Other 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 Posted: July 11, 2007    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: October 2018
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.

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:
Pelvic Pain
Syndrome
Somatoform Disorders
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