Activation of the Sphingosine-1-phosphate (S1P) to S1P1 Receptor Subtype (S1PR1) Axis in Patients With Endometriosis: Identification of Potential Relevant Biomarkers to Diagnose and Treat (S1P1)

Patients seen at the SLUCare Center for Endometriosis (including those with or without pain) undergoing laser excision surgery for known or suspected endometriosis will be recruited for the study.

Per the PI's standard surgical approach to endometriosis, all areas of abnormal peritoneum will be excised (removed).

After surgical excision has been performed, in order to provide standardized specimens for our research, a 3mm punch biopsy will be obtained from the excised peritoneum tissue. The 3 mm biopsy will be sent for research analysis, and the rest of the excised peritoneum tissue will be sent to histology (SSM) for evaluation and classification as having endometriosis or not. For each patient in the study, blood will also be collected to look for markers for endometriosis.

Study Overview

• Status: Completed
• Conditions: Endometriosis

Detailed Description

The study is investigator-initiated, prospective, comparative study. Laparoscopic surgery for endometriosis on patients presenting with pain, infertility or both will be performed by the principal investigator at St. Mary's Hospital. We will be collecting preoperative, operative and postoperative follow-up data on all patients recruited for this study based on comprehensive preoperative questionnaires, which includes data collection on pain scores (by VAS scales) and standardized QOL scales, and the 6-12 month follow questionnaire. The surgical approach in the treatment of endometriosis is by excision only, so that all lesions (abnormal areas of peritoneum) are excised resulting in tissue specimens that are classified at a histologic level, which is the gold standard way to diagnose the presence of endometriosis.

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63117
      • SSM St. Mary's

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 55 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Patients seen at the Center for Endometriosis (including those with or without pain) undergoing laser excision surgery for known or suspected endometriosis will be recruited for the study.

Description

Inclusion Criteria:

• Patients seen at the Center for Endometriosis (including those with or without pain) who are undergoing excision surgery.
• Patients who are undergoing laser excision surgery for known or suspected endometriosis will be recruited for the study.
• Completed a preoperative questionnaire

Exclusion Criteria:

• prior bilateral salpingo-oophorectomy
• post natural menopause

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
S1PR1 levels in PBLs with and without endometriosis.	To determine if S1PR1 levels in PBLs can discriminate between patients with endometriosis and patients without endometriosis.	At Surgery

Collaborators and Investigators

• Sponsor: St. Louis University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): September 10, 2020
• Study Completion (Actual): September 10, 2020

Study Registration Dates

• First Submitted: October 4, 2016
• First Submitted That Met QC Criteria: November 22, 2016
• First Posted (Estimate): November 25, 2016

Study Record Updates

• Last Update Posted (Actual): September 10, 2020
• Last Update Submitted That Met QC Criteria: September 9, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endometriosis
• Other Study ID Numbers: 25996

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No