[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT00499317":3,"trial-entities:NCT00499317":104,"trial-summary:NCT00499317":111},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":23,"study_type":30,"primary_purpose":31,"phases":32,"enrollment_info":33,"interventions":36,"primary_outcomes":37,"secondary_outcomes":42,"sex":43,"minimum_age":31,"maximum_age":31,"healthy_volunteers":44,"eligibility_criteria":45,"std_ages":64,"locations":68,"central_contacts":87,"overall_officials":89,"references":91,"see_also_links":103},"NCT00499317","04-11-160M","Genetic Study of Chronic Prostatitis\u002FChronic Pelvic Pain Syndrome (CP\u002FCPPS)","RECRUITING","2028-12-31","2026-06","2026-06-11","2007-01-15","Boston Children's Hospital","OTHER",true,"Chronic Prostatitis\u002FChronic Pelvic Pain Syndrome (CP\u002FCPPS) 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.\n\nIn this study, we are collecting genetic material and medical information to try to determine if genetic factors play a role in CP\u002FCPPS. We will be collecting DNA (from Blood\u002FSaliva sample) and urine from each participant. Bladder tissue from affected individuals will also be collected. Individuals and families with CP\u002FCPPS will be enrolled. Family members of an individual with CP\u002FCPPS are eligible whether or not they also experience CP\u002FCPPS symptoms.","We would like to determine if chronic prostatitis\u002Fchronic pelvic pain syndrome (CP\u002FCPPS) has a genetic cause. We will be attempting to further describe the symptoms of CP\u002FCPPS 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\u002FSaliva), 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.",[18,19,20,21,22],"Chronic Prostatitis (CP)","Chronic Pelvic Pain Syndrome (CPPS)","Painful Bladder Syndrome (PBS)","Benign Frequency Syndrome (BFS)","Interstitial Cystitis",[24,25,26,27,28,29],"Urgency","Frequency","Pelvic pain","Sexual dysfunction","Erectile dysfunction","Painful intercourse","OBSERVATIONAL",null,[],{"count":34,"type":35},500,"ESTIMATED",[],[38],{"measure":39,"description":40,"timeFrame":41},"Participants With Candidate Disease-Causing Genetic Variant(s) Associated With CP\u002FCPPS or IC\u002FBPS","DNA from blood\u002Fsaliva and, when available, bladder or skin tissue will be analyzed using linkage analysis, whole exome\u002Fgenome sequencing, and candidate gene approaches to identify candidate disease-causing variants associated with CP\u002FCPPS, IC\u002FBPS, PBS, or BFS. The measure will be summarized as the number of participants with candidate disease-causing variant(s), and when applicable, co-segregation of variants with affected status or symptoms.","From enrollment until completion of genetic analysis for the participant or family, up to 22 years.",[],"ALL",false,{"inclusion":46,"exclusion":57,"raw_text":63},[47,48,49,50,51,52,53,54,55,56],"Have symptoms for at least 3 months within the preceding 6 months:","Pain in the pelvic area","Urinary frequency and\u002For","Urinary urgency and\u002For","Sexual dysfunction (erectile dysfunction)","Have CP\u002FCPPS, Interstitial Cystitis (IC), Bladder Pain Syndrome BPS, or Bladder Fasciculation Syndrome (BFS)","Be willing to provide a blood\u002Fsaliva, bladder tissue (from previous biopsy) and urine sample","Agree to complete several brief questionnaires","Family member of someone with CP\u002FCPPS, BPS, IC or BFS","Live in the USA or Canada",[58,59,60,61,62],"Major structural\u002Fanatomical urinary tract abnormalities","Underlying inborn or congenital conditions which affect the urinary tract","Surgery\u002Fchemotherapy in the pelvic area","Bacterial cause to CP\u002FCPPS or recurrent Urinary tract infections (UTI)","Traumatic cause to CP\u002FCPPS","Inclusion Criteria:\n\n* Have symptoms for at least 3 months within the preceding 6 months:\n* Pain in the pelvic area\n* Urinary frequency and\u002For\n* Urinary urgency and\u002For\n* Sexual dysfunction (erectile dysfunction)\n* Have CP\u002FCPPS, Interstitial Cystitis (IC), Bladder Pain Syndrome BPS, or Bladder Fasciculation Syndrome (BFS)\n* Be willing to provide a blood\u002Fsaliva, bladder tissue (from previous biopsy) and urine sample\n* Agree to complete several brief questionnaires\n* Family member of someone with CP\u002FCPPS, BPS, IC or BFS\n* Live in the USA or Canada\n\nExclusion Criteria:\n\n* Major structural\u002Fanatomical urinary tract abnormalities\n* Underlying inborn or congenital conditions which affect the urinary tract\n* Surgery\u002Fchemotherapy in the pelvic area\n* Bacterial cause to CP\u002FCPPS or recurrent Urinary tract infections (UTI)\n* Traumatic cause to CP\u002FCPPS",[65,66,67],"CHILD","ADULT","OLDER_ADULT",[69],{"facility":70,"status":7,"city":71,"state":72,"zip":73,"country":74,"contacts":75,"geoPoint":84},"Boston Children's Hospital (BCH)","Boston","Massachusetts","02115","United States",[76,81],{"name":77,"role":78,"phone":79,"email":80},"Elicia Estrella, MS, LCGC","CONTACT","617-919-4552","elicia.estrella@childrens.harvard.edu",{"name":82,"role":83},"Catherine Brownstein, PhD","PRINCIPAL_INVESTIGATOR",{"lat":85,"lon":86},42.35843,-71.05977,[88],{"name":77,"role":78,"phone":79,"email":80},[90],{"name":82,"affiliation":12,"role":83},[92,96,99],{"pmid":93,"type":94,"citation":95},"12031372","BACKGROUND","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\u002Fchronic pelvic pain syndrome. Urology. 2002 Jun;59(6):870-6. doi: 10.1016\u002Fs0090-4295(02)01601-1.",{"pmid":97,"type":94,"citation":98},"26919663","Keay SK, Zhang CO. Abnormal Akt signalling in bladder epithelial cell explants from patients with interstitial cystitis\u002Fbladder pain syndrome can be induced by antiproliferative factor treatment of normal bladder cells. BJU Int. 2016 Jul;118(1):161-72. doi: 10.1111\u002Fbju.13457. Epub 2016 Mar 29.",{"pmid":100,"type":101,"citation":102},"11489726","RESULT","Dimitrakov JD. A case of familial clustering of interstitial cystitis and chronic pelvic pain syndrome. Urology. 2001 Aug;58(2):281. doi: 10.1016\u002Fs0090-4295(01)01138-4.",[],{"nct_id":4,"conditions":105,"biomarkers":110},[106,107,108,109,22],"Benign Frequency Syndrome","Chronic primary bladder pain syndrome","Chronic primary pelvic pain syndrome","Chronic Prostatitis",[],{"nct_id":4,"found":14,"summary":112,"prompt_version":122},{"design":113,"status":114,"heading":115,"summary":116,"follow_up":117,"word_count":118,"commitments":119,"compensation":120,"drugs_mentioned":121},"This is an observational study planning to enroll 500 participants. It is not testing any specific interventions or drugs.","completed","Genetic Study of Chronic Prostatitis\u002FChronic Pelvic Pain Syndrome","This study is looking into whether genetic factors play a role in chronic prostatitis\u002Fchronic pelvic pain syndrome (CP\u002FCPPS), a condition with pain in the pelvic area, urinary issues, or sexual dysfunction. Researchers believe some types of CP\u002FCPPS might be inherited. You may be able to join if you have CP\u002FCPPS, Interstitial Cystitis (IC), Bladder Pain Syndrome (BPS), or Bladder Fasciculation Syndrome (BFS) with symptoms for at least 3 months in the past 6 months. Family members of someone with CP\u002FCPPS can also join, even if they don't have symptoms. The study aims to find specific genetic changes linked to these conditions. This is an observational study, meaning no new treatments are being tested.","Participants will be followed from enrollment until the completion of genetic analysis, which could be up to 22 years.",113,"You would provide a blood or saliva sample, a urine sample, and answer questionnaires. If you are an affected participant, you may also be asked to provide a bladder sample from a clinical biopsy.","Not stated in the trial record.",[],"v2"]