Trials / Completed
CompletedNCT02973854
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
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 80 (actual)
- Sponsor
- St. Louis University · Academic / Other
- Sex
- Female
- Age
- 13 Years – 55 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Timeline
- Start date
- 2016-09-01
- Primary completion
- 2020-09-10
- Completion
- 2020-09-10
- First posted
- 2016-11-25
- Last updated
- 2020-09-10
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02973854. Inclusion in this directory is not an endorsement.