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

NCT02973854 | Completed

• 1 other identifier: 25996
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 13 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• prior bilateral salpingo-oophorectomy
• post natural menopause

Sponsors & Collaborators

• St. Louis University: lead

Study Sites (1)

SSM St. Mary's

St Louis, Missouri, 63117, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 4, 2016
• First Posted: November 25, 2016
• Study Start: September 1, 2016
• Primary Completion: September 10, 2020
• Study Completion: September 10, 2020
• Last Updated: September 10, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)