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Genetic and Histopathologic Characteristics of Interstitial Cystitis

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ClinicalTrials.gov Identifier: NCT03523559
Recruitment Status : Recruiting
First Posted : May 14, 2018
Last Update Posted : September 20, 2021
Sponsor:
Information provided by (Responsible Party):
KYU-SUNG LEE, Samsung Medical Center

Study Description
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Brief Summary:
Genetic and Histopathologic Characteristics of Interstitial Cystitis

Condition or disease Intervention/treatment
Interstitial Cystitis Genetic: bladder tissue of Interstitial Cystitis and normal bladder tissue

Study Design
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Study Type : Observational
Estimated Enrollment : 15 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Genetic and Histopathologic Characteristics of Interstitial Cystitis
Actual Study Start Date : March 31, 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Interstitial Cystitis Genetic: bladder tissue of Interstitial Cystitis and normal bladder tissue
Obtain the bladder tissue of Interstitial Cystitis and normal during the operation
normal Genetic: bladder tissue of Interstitial Cystitis and normal bladder tissue
Obtain the bladder tissue of Interstitial Cystitis and normal during the operation


Outcome Measures
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Primary Outcome Measures :
  1. Genetic differences between ulcer and non-ulcer of bladder in Interstitial Cystitis [ Time Frame: 30days ]
  2. Genetic differences between bladder tissue of Interstitial Cystitis and normal bladder tissue [ Time Frame: 30days ]

Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
  • Patients diagnosed with Hunner lesion in Interstitial cystitis and who is scheduled to undergo transurethral resection
  • Patients diagnosed with Bladder cancer and who is scheduled to undergo cystectomy
Criteria

Inclusion Criteria:

  • Male and female aged 19 yrs or greater
  • Patients diagnosed with Hunner lesion in Interstitial cystitis and who is scheduled to undergo transurethral resection
  • Patients diagnosed with Bladder cancer and who is scheduled to undergo cystectomy

Exclusion Criteria:

  • Male and female under aged 20 yrs
  • A person whose area of bladder cancer is larger than that of the normal area
  • A person who is going to have a cystectomy after chemotherapy on bladder cancer
Contacts and Locations
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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): NCT03523559


Contacts
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Contact: sangok park 82-2-6007-5419 missusu@naver.com

Locations
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Korea, Republic of
Samsung Medical Center, Sungkyunkwan University School of Medicine Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Kyu-Sung Lee, MD, PhD    82-2-3410-3554    ksleedr@skku.edu   
Principal Investigator: Kyu-Sung Lee, MD, PhD         
Sponsors and Collaborators
Samsung Medical Center
More Information
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Responsible Party: KYU-SUNG LEE, professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT03523559    
Other Study ID Numbers: 2018-03-025
First Posted: May 14, 2018    Key Record Dates
Last Update Posted: September 20, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cystitis
Cystitis, Interstitial
Urinary Bladder Diseases
Urologic Diseases