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

Endometriosis Clinical Trial

— S1P1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02973854
• Other study ID #: 25996
• Status: Completed
• Start date: September 2016
• Est. completion date: September 10, 2020

Study information

• Verified date: September 2020
• Source: St. Louis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 10, 2020
• Est. primary completion date: September 10, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 13 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometriosis

Locations

Country	Name	City	State
United States	SSM St. Mary's	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
St. Louis University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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