S1P1 Receptor Subtype (S1PR1) Axis in Patients With Inter... | NCT03003845

Studies
S1P1 Receptor Subtype (S1PR1) Axis in Patients With Interstitial Cystitis (IC) Pain

NCT03003845

Sponsor

St. Louis University

Status

Completed

Last Update Posted

Jul 23, 2021Actual

Enrollment

21Actual

Phase

Not provided

Conditions

Interstitial Cystitis

Interventions

Questionnaires
Collection of Blood samples

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 26, 2019Actual

Primary Completion Date

Feb 27, 2020Actual

Completion Date

Feb 27, 2020Actual

First Submitted Date

Nov 22, 2016

First Submission Date that Met QC Criteria

Dec 22, 2016

First Posted Date

Dec 28, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 22, 2021

Last Update Posted Date

Jul 23, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

21Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Interstitial Cystitis		Patients with Interstitial Cystitis will be followed with Questionnaires and blood collection at 3, 6,and 12 months	Other: Questionnaires Other: Collection of Blood samples

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Questionnaires	Other	QOL and pain questionnaires will be given to patients at 3, 6, and 12 months post surgery	Interstitial Cystitis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18-70 years of age
Patients must be able to provide written informed consent.
Diagnosis of Interstitial Cystitis documented by provider

Exclusion Criteria:

age <18 or >70 years of age
pregnant

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder 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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eugen C Campian, MD	St. Louis University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Saint Louis University Department of Obstetrics, Gynecology, and Women's Health		St Louis	Missouri	63117	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D018856	Cystitis, Interstitial

Ancestor Terms

ID	Term
D003556	Cystitis
D001745	Urinary Bladder Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011795	Surveys and Questionnaires

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided

Description

PERIPHERAL BLOOD LEUKOCYTE (PBLS) ANALYSIS (Research Related):

Using immunoblotting, we will determine if the level of S1PR1 expression in peripheral blood leukocytes (PBLs) is increased in patients with IC pain. Patients will have blood samples taken, at the visit they sign the consent form 3 and 6 months later. A total of 4 teaspoons of blood will be taken for the study.