CHU de Nantes
Nantes, 44093, France
Location status: Recruiting
NCT Number: NCT06820450
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.
Interested in participating?
Request Info18 year–45 year
Female
Observational
Nantes, 44093, France
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Specific inclusion criteria for each group:
Group 1. Controls.
Group 2. Cases of deep endometriosis.
Exclusion criteria
A blood test (2 x 5 ml dry tubes) will be taken to analyze steroid profiles
a 20 ml urine sample will be taken to analyze steroid profiles
to characterize the microbiota.
Time frame: Sampling at inclusion visit
Statistical associations between steroids and the presence of endometriosis.
Time frame: Sampling at inclusion visit
Statistical difference between environmental chemical and steroid exposure profiles between subgroups of the study populations.
Time frame: Sampling at inclusion visit
Presence of a specific bacterial community in the vaginal microbiota
Contact information is provided by the study sponsor or research team.
Nantes University Hospital
Other
STERONLINE: Steroidome and Exposome of Endometriosis Single-center Case-control Study
Acronym: STERONLINE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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