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

NCT ID: NCT00499317

Last Updated: 2023-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-01-15

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Chronic Prostatitis (CP) Chronic Pelvic Pain Syndrome (CPPS) Painful Bladder Syndrome (PBS) Benign Frequency Syndrome (BFS) Interstitial Cystitis

Study Design

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Observational Model Type

FAMILY_BASED

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Boston Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Catherine Brownstein

Assoc. Professor of Genetics and Pediatrics, Harvard Medical School

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Catherine Brownstein, PhD

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Locations

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Boston Children's Hospital (BCH)

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Elicia Estrella, MS, LCGC

Role: CONTACT

617-919-4552

Facility Contacts

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Elicia Estrella, MS, LCGC

Role: primary

617-919-4552

References

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Propert KJ, Alexander RB, Nickel JC, Kusek JW, Litwin MS, Landis JR, Nyberg LM, Schaeffer AJ; Chronic Prostatitis Collaborative Research Network. Design of a multicenter randomized clinical trial for chronic prostatitis/chronic pelvic pain syndrome. Urology. 2002 Jun;59(6):870-6. doi: 10.1016/s0090-4295(02)01601-1.

Reference Type BACKGROUND
PMID: 12031372 (View on PubMed)

Keay SK, Zhang CO. Abnormal Akt signalling in bladder epithelial cell explants from patients with interstitial cystitis/bladder pain syndrome can be induced by antiproliferative factor treatment of normal bladder cells. BJU Int. 2016 Jul;118(1):161-72. doi: 10.1111/bju.13457. Epub 2016 Mar 29.

Reference Type BACKGROUND
PMID: 26919663 (View on PubMed)

Dimitrakov JD. A case of familial clustering of interstitial cystitis and chronic pelvic pain syndrome. Urology. 2001 Aug;58(2):281. doi: 10.1016/s0090-4295(01)01138-4.

Reference Type RESULT
PMID: 11489726 (View on PubMed)

Other Identifiers

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91208

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

04-11-160M

Identifier Type: -

Identifier Source: org_study_id

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