Идёт набор NCT06820450

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

— Наблюдательное Endometriosis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Blood test, urine sample, vaginal sample.
Кому может быть актуально: Состояния в реестре: Endometriosis. Базовые параметры: 18 лет — 45 лет · Женщины.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Франция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

Identify steroid profiles associated with endometriosis [Срок оценки: Sampling at inclusion visit]

Вторичные конечные точки (2)

Identify biomarkers of environmental chemical exposure associated with endometriosis and steroid profiles. [Срок оценки: Sampling at inclusion visit]
Identify the role of vaginal microbiota dysbiosis on hormonal alteration in endometriosis [Срок оценки: Sampling at inclusion visit]

Критерии участия

Критерии включения

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).