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

NCT06820450 | Not Yet Recruiting

• 1 other identifier: RC24_0498
• Study Type: observational
• Target: 135
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Endometriosis

Keywords

Steroidome; exposome; LC-HRMS

Outcome Measures

Primary Outcomes (1)

• Identify steroid profiles associated with endometriosis

  Statistical associations between steroids and the presence of endometriosis.

  Sampling at inclusion visit

Secondary Outcomes (2)

• Identify biomarkers of environmental chemical exposure associated with endometriosis and steroid profiles.

  Sampling at inclusion visit

• Identify the role of vaginal microbiota dysbiosis on hormonal alteration in endometriosis

  Sampling at inclusion visit

Study Arms (2)

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; Other: urine sample; Other: vaginal sample

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; Other: urine sample; Other: vaginal sample

Interventions

Blood test OTHER

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

Group 1. Controls (n=45); Group 2. Deep endometriosis (n = 90)

urine sample OTHER

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

Group 1. Controls (n=45); Group 2. Deep endometriosis (n = 90)

vaginal sample OTHER

to characterize the microbiota.

Group 1. Controls (n=45); Group 2. Deep endometriosis (n = 90)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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
• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Nantes University Hospital: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

A 10 ml blood sample (2 x 5 ml tubes) and a 20 ml urine sample for steroid profile analysis; A vaginal swab to characterise your microbiota.

MeSH Terms

Conditions

Endometriosis

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Central Study Contacts

Stéphane PLOTEAU, PU-PH

CONTACT

02.40.08.76.84; Stéphane.ploteau@chu-nantes.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: February 11, 2025
• Study Start: July 15, 2025
• Primary Completion: March 15, 2026
• Study Completion (Estimated): March 15, 2027
• Last Updated: May 29, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share