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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
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06820450
Acronym
STERONLINE
Enrollment
135
Registered
2025-02-11
Start date
2025-07-01
Completion date
2027-07-01
Last updated
2026-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometriosis

Keywords

Steroidome, exposome, LC-HRMS

Brief 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.

Interventions

OTHERBlood test

A blood test (2 x 5 ml dry tubes) will be taken to analyze steroid profiles

OTHERurine sample

a 20 ml urine sample will be taken to analyze steroid profiles

to characterize the microbiota.

Sponsors

Nantes University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Identify steroid profiles associated with endometriosisSampling at inclusion visitStatistical associations between steroids and the presence of endometriosis.

Secondary

MeasureTime frameDescription
Identify biomarkers of environmental chemical exposure associated with endometriosis and steroid profiles.Sampling at inclusion visitStatistical difference between environmental chemical and steroid exposure profiles between subgroups of the study populations.
Identify the role of vaginal microbiota dysbiosis on hormonal alteration in endometriosisSampling at inclusion visitPresence of a specific bacterial community in the vaginal microbiota

Countries

France

Contacts

CONTACTStéphane PLOTEAU, PU-PH
Stéphane.ploteau@chu-nantes.fr02.40.08.76.84

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 25, 2026