Pilot Study to Characterize the Endometriosis Steroidome and Its Link to Endocrine Disruptors and Vaginal Dysbiosis
NCT ID: NCT06820450
Last Updated: 2025-05-29
Study Results
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Basic Information
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NOT_YET_RECRUITING
135 participants
OBSERVATIONAL
2025-07-15
2027-03-15
Brief Summary
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Detailed Description
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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
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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.
Blood test
A blood test (2 x 5 ml dry tubes) will be taken to analyze steroid profiles
urine sample
a 20 ml urine sample will be taken to analyze steroid profiles
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.
Blood test
A blood test (2 x 5 ml dry tubes) will be taken to analyze steroid profiles
urine sample
a 20 ml urine sample will be taken to analyze steroid profiles
vaginal sample
to characterize the microbiota.
Interventions
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Blood test
A blood test (2 x 5 ml dry tubes) will be taken to analyze steroid profiles
urine sample
a 20 ml urine sample will be taken to analyze steroid profiles
vaginal sample
to characterize the microbiota.
Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
* Presence of other hormone-dependent pathologies (e.g. breast cancer, PCOS).
* Acute infection.
18 Years
45 Years
FEMALE
No
Sponsors
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Nantes University Hospital
OTHER
Responsible Party
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Central Contacts
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Other Identifiers
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RC24_0498
Identifier Type: -
Identifier Source: org_study_id
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