Interstitial CystitisS1P1NCT03003845
S1P1 Receptor Subtype (S1PR1) Axis in Patients With Interstitial Cystitis (IC) Pain
An observational study of Interstitial Cystitis, run by St. Louis University at 1 site in United States.
Trial summary
For each patient in the study, blood, and pain scores will be collected to look for markers for pain, at the start of treatment and 6 months after surgery of treatment. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Interstitial Cystitis
- What is being tested?
- Questionnaires and Collection of Blood samples
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2019to 27 Feb 2020
- How long will I take part?
- 3 Months
- 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 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women are included. The onset of interstitial cystitis usually occurs between 30 and 70 years of age, with a median age of 43. .
Who may be able to join
- 18-70 years of age
- Patients must be able to provide written informed consent.
- Diagnosis of Interstitial Cystitis documented by provider
Who cannot join
- age <18 or >70 years of age
- pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Saint Louis University Department of Obstetrics, Gynecology, and Women's Health
St Louis, Missouri, 63117
About this study
Official title: Activation of the Sphingosine-1-phosphate (S1P) to S1P1 Receptor Subtype (S1PR1) Axis in Patients With Interstitial Cystitis (IC) Pain : Identification of Potential Relevant Biomarkers
For each patient in the study, blood, and pain scores will be collected to look for markers for pain, at the start of treatment and 6 months after surgery of treatment.
Read the detailed description
The study is investigator-initiated, prospective, study. There will be no change in care.
Patients who have had a diagnosis of IC made by cystoscopy and hydrodistension and still have pain will be recruited for this study.
Patients will have blood samples taken at the visit they sign the consent form and 6 months later.
The study staff will call and remind the patient of their 6 month visit.
- Conditions
- Interstitial Cystitis
- Being tested
- Questionnaires, Collection of Blood samples
- Medical subject headings
- Cystitis, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
QOL and pain questionnaires will be given to patients at 3, 6, and 12 months post surgery
Collection of Blood samplesOther
Blood for PBLs will be collected at 3, 6, and 12 months post surgery
| Study group | Role | What they receive |
|---|---|---|
| Interstitial Cystitis | Patients with Interstitial Cystitis will be followed with Questionnaires and blood collection at 3, 6,and 12 months Receives: Other: Questionnaires; Other: Collection of Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Pain Scores on the Visual Analog Scale at 6 months
S1PR1 levels in PBLs can discriminate patients with Interstitial Cystitis pain and patients with other types of pain.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2016 (estimated)
- Study start26 Feb 2019
- Primary completion27 Feb 2020
- Study completion27 Feb 2020
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.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- St. Louis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eugen C. Campian, MD, St. Louis University
- Investigators
- Eugen C Campian, MD, Principal investigator, St. Louis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03003845
- Sponsor's protocol ID
- 27338
- Acronym
- S1P1
- Status last verified
- Jul 2021
- First submitted
- 22 Nov 2016
- Last updated
- 23 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Activation of the Sphingosine-1-phosphate (S1P) to S1P1 Receptor Subtype (S1PR1) Axis in Patients With Interstitial Cystitis (IC) Pain : Identification of Potential Relevant Biomarkers
- ClinicalTrials.gov ID
- NCT03003845
- Acronym / sponsor ID
- S1P1 / 27338
- Conditions
- Interstitial Cystitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- St. Louis UniversityUniversity, hospital or other
- Study start
- 26 Feb 2019 (actual)
- Primary completion
- 27 Feb 2020 (actual)
- Study completion
- 27 Feb 2020 (actual)
- First posted
- 28 Dec 2016 (estimated)
- 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.
For each patient in the study, blood, and pain scores will be collected to look for markers for pain, at the start of treatment and 6 months after surgery of treatment.
Detailed description
The study is investigator-initiated, prospective, study. There will be no change in care.
Patients who have had a diagnosis of IC made by cystoscopy and hydrodistension and still have pain will be recruited for this study.
Patients will have blood samples taken at the visit they sign the consent form and 6 months later.
The study staff will call and remind the patient of their 6 month visit.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interstitial Cystitis | – | Other: Questionnaires, Other: Collection of Blood samplesPatients with Interstitial Cystitis will be followed with Questionnaires and blood collection at 3, 6,and 12 months |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women are included. The onset of interstitial cystitis usually occurs between 30 and 70 years of age, with a median age of 43. .
Key inclusion criteria (3 listed)
- 18-70 years of age
- Patients must be able to provide written informed consent.
- Diagnosis of Interstitial Cystitis documented by provider
Key exclusion criteria (2 listed)
- age <18 or >70 years of age
- pregnant
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 |
|---|---|---|
| QuestionnairesQOL and pain questionnaires will be given to patients at 3, 6, and 12 months post surgery | Other | Interstitial Cystitis |
| Collection of Blood samplesBlood for PBLs will be collected at 3, 6, and 12 months post surgery | Other | Interstitial Cystitis |
Primary outcome
Change From Baseline in Pain Scores on the Visual Analog Scale at 6 months
Time frame: 3 months
S1PR1 levels in PBLs can discriminate patients with Interstitial Cystitis pain and patients with other types of pain.
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 23 Jul 2021.
- 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.
Eugen C Campian, MD principal investigator
St. Louis University
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 St. Louis University at 1 site in United States.
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 2 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 23 Jul 2021. 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 United States. 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?
Change From Baseline in Pain Scores on the Visual Analog Scale at 6 months (time frame: 3 months). 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 23 Jul 2021; AzTrials last refreshed its copy on 6 Nov 2026.