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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Endometriosis
• Intervention / Treatment: Other: Blood test; Other: urine sample; Other: vaginal sample

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.

• Study Type: Observational
• Enrollment (Estimated): 135
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stéphane PLOTEAU, PU-PH; Phone Number: +33 02.40.08.76.84; Email: Stéphane.ploteau@chu-nantes.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The STERONLINE study population will be made up of women aged between 18 years and 45 years

• 45 patients with endometrioma
• 45 patients without endometrioma

Description

Inclusion Criteria:

• Women aged 18 to 45
• Free, informed and written consent from the patient to participate in the study
• Good understanding of the French language
• Patient affiliated to or benefiting from a social security or similar scheme

Specific inclusion criteria for each group:

Group 1. Controls.

• Women with no laparoscopically confirmed signs suggestive of deep endometriosis.
• No clinico-biological criteria in favour of a diagnosis of endometriotic disease, nor any radiological signs (ultrasound or MRI) suggestive of endometriosis.

Group 2. Cases of deep endometriosis.

• Newly diagnosed women (less than 12 months).
• Severe, deep endometriotic pathology with surgical indication (clinical examination, imaging tests, pre-operative findings).

Exclusion Criteria:

• Intercurrent diagnosis of pregnancy.
• Presence of other hormone-dependent pathologies (e.g. breast cancer, PCOS).
• Acute infection.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1. Controls (n=45); Women with no laparoscopically confirmed signs of deep endometriosis.; No clinico-biological criteria in favour of a diagnosis of endometriotic disease, nor any radiological signs (ultrasound or MRI) suggestive of endometriosis. A blood test (2 x 5 ml dry tubes) and a 20 ml urine sample will be taken to analyze steroid profiles, as well as a vaginal sample to characterize the microbiota.	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.
Group 2. Deep endometriosis (n = 90); 45 patients with endometriome; 45 patients without endometriome Deep endometriosis confirmed by surgery or MRI Newly diagnosed women (less than 12 months).; Severe, deep-seated endometriotic pathology with surgical indication (clinical examination, imaging tests, pre-operative findings). A blood test (2 x 5 ml dry tubes) and a 20 ml urine sample will be taken to analyze steroid profiles, as well as a vaginal sample to characterize the microbiota.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identify steroid profiles associated with endometriosis	Statistical associations between steroids and the presence of endometriosis.	Sampling at inclusion visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identify biomarkers of environmental chemical exposure associated with endometriosis and steroid profiles.	Statistical difference between environmental chemical and steroid exposure profiles between subgroups of the study populations.	Sampling at inclusion visit
Identify the role of vaginal microbiota dysbiosis on hormonal alteration in endometriosis	Presence of a specific bacterial community in the vaginal microbiota	Sampling at inclusion visit

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): July 15, 2025
• Primary Completion (Estimated): March 15, 2026
• Study Completion (Estimated): March 15, 2027

Study Registration Dates

• First Submitted: February 5, 2025
• First Submitted That Met QC Criteria: February 5, 2025
• First Posted (Actual): February 11, 2025

Study Record Updates

• Last Update Posted (Actual): May 29, 2025
• Last Update Submitted That Met QC Criteria: May 23, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: exposome; Steroidome; LC-HRMS
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Endometriosis
• Other Study ID Numbers: RC24_0498

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No