Interstitial CystitisNCT03523559
Genetic and Histopathologic Characteristics of Interstitial Cystitis
An observational study of Interstitial Cystitis, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Genetic and Histopathologic Characteristics of Interstitial Cystitis Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Interstitial Cystitis
- What is being tested?
- bladder tissue of Interstitial Cystitis and normal bladder tissue
- How many people
- 14 participants
- Where
- 1 siteSouth Korea
- Study dates
- 31 Mar 2018to 29 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Samsung Medical Center, Sungkyunkwan University School of Medicine
Seoul, 135-710
About this study
Genetic and Histopathologic Characteristics of Interstitial Cystitis
- Conditions
- Interstitial Cystitis
- Being tested
- bladder tissue of Interstitial Cystitis and normal bladder tissue
- Medical subject headings
- Cystitis, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bladder tissue of Interstitial Cystitis and normal bladder tissueGenetic
Obtain the bladder tissue of Interstitial Cystitis and normal during the operation
| Study group | Role | What they receive |
|---|---|---|
| Interstitial Cystitis | Not described Receives: Genetic: bladder tissue of Interstitial Cystitis and normal bladder tissue | |
| normal | Not described Receives: Genetic: bladder tissue of Interstitial Cystitis and normal bladder tissue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genetic differences between ulcer and non-ulcer of bladder in Interstitial Cystitis
Measured: 30days
Genetic differences between bladder tissue of Interstitial Cystitis and normal bladder tissue
Measured: 30days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2018
- Study start31 Mar 2018
- Primary completion31 Dec 2023
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial CystitisStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, KYU-SUNG LEE, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03523559
- Sponsor's protocol ID
- 2018-03-025
- Status last verified
- Oct 2024
- First submitted
- 1 May 2018
- Last updated
- 29 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic and Histopathologic Characteristics of Interstitial Cystitis
- ClinicalTrials.gov ID
- NCT03523559
- Acronym / sponsor ID
- 2018-03-025
- Conditions
- Interstitial Cystitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 31 Mar 2018 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 14 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Genetic and Histopathologic Characteristics of Interstitial Cystitis
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interstitial Cystitis | – | Genetic: bladder tissue of Interstitial Cystitis and normal bladder tissue |
| normal | – | Genetic: bladder tissue of Interstitial Cystitis and normal bladder tissue |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bladder tissue of Interstitial Cystitis and normal bladder tissueObtain the bladder tissue of Interstitial Cystitis and normal during the operation | Genetic | Interstitial Cystitis, normal |
Primary outcome
Genetic differences between ulcer and non-ulcer of bladder in Interstitial Cystitis
Time frame: 30days
Genetic differences between bladder tissue of Interstitial Cystitis and normal bladder tissue
Time frame: 30days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Interstitial Cystitis, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genetic differences between ulcer and non-ulcer of bladder in Interstitial Cystitis (time frame: 30days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2024.