NCT06820450

Pilot Study to Characterize the Endometriosis Steroidome and Its Link to Endocrine Disruptors and Vaginal Dysbiosis

STERONLINE: Steroidome and Exposome of Endometriosis Single-center Case-control Study

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 135 (estimated)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

Endometriosis is a systemic, steroid-dependent, inflammatory disease characterized by the growth of endometrial-like tissue outside the uterus, affecting approximately 10 % of women of childbearing age. The etiology and pathophysiology of endometriosis is not completely understood to support effective treatment and prevention strategies. Despite the steroid dependency, little is known concerning the underlying metabolism of estrogen and other tightly related steroids. Moreover, shortening the long diagnostic delays is a major priority in endometriosis research.

Detailed description

The main aim of the study will be to develop a global steroidomics analytical strategy " fit-for-purpose" to improve the knowledge of endometriosis pathophysiology and boost the identification of diagnostic biomarkers. Therefore, in a first step, a new analytical method will be developed adapting state-of-the-art liquid chromatography coupled to high resolution mass spectrometry (LC-HRMS) approaches for steroids and its metabolites towards endometriosis research. The investigators will ensure the characterization of established steroids and its metabolites known to be relevant to endometriosis, but also expand the panel with non-targeted methods to identify phase-1 and -2 metabolites potentially informing of novel steroidogenic pathways in serum and urine. In a second phase, a case-control study will be conducted to apply the strategy in a sample of women with and without endometriosis. In a third step, the investigators will explore statistical differences in steroid profiles among endometriosis groups and evaluate the discriminative performance. The proposed method has large applications in endometriosis research and large potential to provide novel clues about the still poorly understood steroid metabolism disruption undergoing in endometriosis. Ultimately, non-invasive biomarker discovery in urine could revolutionize endometriosis diagnosis and management, allowing for earlier detection and personalized treatment strategies, ultimately improving the lives of individuals affected by this often overlooked but debilitating condition. In parallel, the role of dysbiosis of the vaginal microbiota on hormonal alterations linked to endometriosis will be studied.

Conditions

• Endometriosis

Interventions

Type	Name	Description
OTHER	Blood test	A blood test (2 x 5 ml dry tubes) will be taken to analyze steroid profiles
OTHER	urine sample	a 20 ml urine sample will be taken to analyze steroid profiles
OTHER	vaginal sample	to characterize the microbiota.

Timeline

• Start date: 2025-07-15
• Primary completion: 2026-03-15
• Completion: 2027-03-15
• First posted: 2025-02-11
• Last updated: 2025-05-29