S1P1 Receptor Subtype (S1PR1) Axis in Patients With Interstitial Cystitis (IC) Pain (S1P1)
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|ClinicalTrials.gov Identifier: NCT03003845|
Recruitment Status : Recruiting
First Posted : December 28, 2016
Last Update Posted : April 1, 2019
|Condition or disease||Intervention/treatment|
|Interstitial Cystitis||Other: Questionnaires Other: Collection of Blood samples|
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 Type :||Observational [Patient Registry]|
|Estimated Enrollment :||50 participants|
|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|
|Actual Study Start Date :||February 26, 2019|
|Estimated Primary Completion Date :||September 1, 2019|
|Estimated Study Completion Date :||November 1, 2019|
Patients with Interstitial Cystitis will be followed with Questionnaires and blood collection at 3, 6,and 12 months
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
- 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.
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
|Contact: Dana Siegrist, BAemail@example.com|
|Contact: Collin R Miller, MSWfirstname.lastname@example.org|
|United States, Missouri|
|Saint Louis University Department of Obstetrics, Gynecology, and Women's Health||Recruiting|
|Saint Louis, Missouri, United States, 63117|
|Contact: Katherine Mathews, MD 314-977-2083 email@example.com|
|Principal Investigator:||Eugen C Campian, MD||St. Louis University|