Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03003845
Recruitment Status : Not yet recruiting
First Posted : December 28, 2016
Last Update Posted : January 11, 2019
Sponsor:
Information provided by (Responsible Party):
Eugen C. Campian, MD, St. Louis University

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.

Condition or disease Intervention/treatment
Interstitial Cystitis Other: Questionnaires Other: Collection of Blood samples

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.


Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 50 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
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
Estimated Study Start Date : March 1, 2019
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : November 1, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Interstitial Cystitis
Patients with Interstitial Cystitis will be followed with Questionnaires and blood collection at 3, 6,and 12 months
Other: Questionnaires
QOL and pain questionnaires will be given to patients at 3, 6, and 12 months post surgery

Other: Collection of Blood samples
Blood for PBLs will be collected at 3, 6, and 12 months post surgery




Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples With DNA

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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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.

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

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): NCT03003845


Contacts
Layout table for location contacts
Contact: Dana Siegrist, BA 314-977-2200 dana.siegrist@health.slu.edu
Contact: Collin R Miller, MSW 3149776342 collin.miller@health.slu.edu

Sponsors and Collaborators
St. Louis University
Investigators
Layout table for investigator information
Principal Investigator: Eugen C Campian, MD St. Louis University

Additional Information:

Layout table for additonal information
Responsible Party: Eugen C. Campian, MD, Principal Investigator, St. Louis University
ClinicalTrials.gov Identifier: NCT03003845     History of Changes
Other Study ID Numbers: 27338
First Posted: December 28, 2016    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Cystitis
Cystitis, Interstitial
Urinary Bladder Diseases
Urologic Diseases