About this trial
The EUmetriosis project aims to address the most important unmet needs of endometriosis sufferers to advance patient care. The objectives cover all main aspects of disease management, including elucidating the pathogenesis, diagnosing the condition promptly and efficiently, facilitating care by implementing self-management strategies, raising awareness and promoting policy changes. The objectives comprise individual yet intersecting pieces of a puzzle which, when positioned correctly, can immensely improve disease perception and understanding to enhance patient care. The project will prioritise the needs and wants of modern-day patients, focused on providing easily accessible and noninvasive therapeutic options. Combining all these elements in a well-coordinated project is pivotal to relieving the heavy burden endometriosis places on European society as a whole.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Women with a clinical and/or ultrasound diagnosis of endometriosis who are candidates for surgery
Age between 18 and 50 years
Pre-menopausal status
Experiencing regular menstruation
Disqualifiers
Age below 18 years
Post-Menopausal status
Presence of Crohn's disease
Presence of Ulcerative Colitis
Trial population
The University Clinical Hospital No.4 and No.1, 1 Military Clinical Hospital in Lublin SPZOZ
Trial design
Case-control
Other
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Alterations in immune system cell phenotype and activity associated with endometriosis.
High-dimensional flow cytometry (FACS) will be done to analyse immune cells such as Myeloid derived suppressor cells (MDSC) along with the expression of co-inhibitory molecules on their surface. Functional parameters crucial to MDSCs activity will be than investigated (ARG1, IDO, NOS2, IL-10, TGFβ) in endometriosis patients and in the control group, to evaluate their immune profile. Also Natural Killer (NK) cells and γδ T cells along with co-inhibitory (TIGIT, LAG-3, TIM-3,PD-1) and co-stimulatory (CD16, NKG2D and OX40, CD226 (DNAM-1) immune checkpoints expression will be characterised, to determine any differences between patients with and without endometriosis. Functional parameters crucial to NK cells and γδ T lymphocytes activity will be also investigated (CD3ζ (CD247), granzyme B, perforin, and IFN-γ).
Alterations in the level of inflammatory and immunosuppressive cytokines associated with endometriosis.
High-dimensional flow cytometry and ELISA will be done to analyse the level of the soluble forms of immune checkpoint (sTIM-3, sGal-9, sTIGIT, sCD155, LAG-3, sOX40L, sOX40) and soluble factors (IL-1beta, IL-6, IL-8, IL-12p70, IL-2, IL-4, IL-6, IL-10, IL-17A, TNF-α, and IFN-γ) in plasma of patients with endometriosis and the control group.
Locations
Sponsors and contacts
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Medical University of Lublin
Lead sponsor
European Commission
Collaborator
This trial is not recruiting at the moment. You can still explore other options: