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

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.

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Key information

Conditions

Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

13 year–55 year

Sex eligibility

Female

Study type

Observational

Primary location

SSM St. Mary's

St Louis, Missouri, 63117, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

S1PR1 levels in PBLs with and without endometriosis.

Time frame: At Surgery

To determine if S1PR1 levels in PBLs can discriminate between patients with endometriosis and patients without endometriosis.

Sponsors and collaborators

Lead sponsor

St. Louis University

Other

Registry information

Acronym: S1P1

Important dates

Study start: 2016
Primary completion: 2020
Study completion: 2020
First posted: Nov 25, 2016
Registry last updated: Sep 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed