STERONLINE: Steroidome and Exposome of Endometriosis Single-center Case-control Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- Identify steroid profiles associated with endometriosis
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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:
- •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.
- •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).
排除标准
- •Intercurrent diagnosis of pregnancy.
- •Presence of other hormone-dependent pathologies (e.g. breast cancer, PCOS).
- •Acute infection.
研究组 & 干预措施
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.
干预措施: Blood test (Other)
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.
干预措施: urine sample (Other)
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.
干预措施: vaginal sample (Other)
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.
干预措施: Blood test (Other)
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.
干预措施: urine sample (Other)
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.
干预措施: vaginal sample (Other)
结局指标
主要结局
Identify steroid profiles associated with endometriosis
时间窗: Sampling at inclusion visit
Statistical associations between steroids and the presence of endometriosis.
次要结局
- 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)