NCT03523559

Brief Summary

Genetic and Histopathologic Characteristics of Interstitial Cystitis

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 31, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 1, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 14, 2018

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2024

Completed
Last Updated

October 29, 2024

Status Verified

October 1, 2024

Enrollment Period

5.8 years

First QC Date

May 1, 2018

Last Update Submit

October 25, 2024

Conditions

Interstitial Cystitis

Outcome Measures

Primary Outcomes (2)

  • Genetic differences between ulcer and non-ulcer of bladder in Interstitial Cystitis

    30days

  • Genetic differences between bladder tissue of Interstitial Cystitis and normal bladder tissue

    30days

Study Arms (2)

Interstitial Cystitis

Genetic: bladder tissue of Interstitial Cystitis and normal bladder tissue

normal

Genetic: bladder tissue of Interstitial Cystitis and normal bladder tissue

Interventions

bladder tissue of Interstitial Cystitis and normal bladder tissueGENETIC

Obtain the bladder tissue of Interstitial Cystitis and normal during the operation

Interstitial Cystitisnormal

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center, Sungkyunkwan University School of Medicine

Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

Cystitis, Interstitial

Condition Hierarchy (Ancestors)

CystitisUrinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

May 1, 2018

First Posted

May 14, 2018

Study Start

March 31, 2018

Primary Completion

December 31, 2023

Study Completion

February 29, 2024

Last Updated

October 29, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)