Clinical trial · Observational
Characterization of Immune Cells and Their Secreted Cytokines in Endometriosis Patients
"EUmetriosis: Transforming Endometriosis Care in Europe: an Integrated Approach to Enhance Understanding, Diagnosis, Tailored Management and Patient Empowerment
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometriosis | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- study group
- description
- pre-menopausal adult women with clinically and/or ultrasound-diagnosed endometriosis, age between 18 and 40 years, with regular menstruation, without autoimmune diseases, without malignant diseases
Primary outcomes (2)
- measure
- Alterations in immune system cell phenotype and activity associated with endometriosis.
- timeFrame
- The collection of peripheral blood samples will be done at a single time point before the surgery. Collection of menstrual effluent in the form of a menstrual cup on the 2nd day of the menstrual cycle.
- description
- 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).
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * 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 * Willing to collect menstrual effluent * Signature of informed consent to the study Exclusion Criteria: * Age below 18 years * Post-Menopausal status * Presence of Crohn's disease * Presence of Ulcerative Colitis * Presence of short bowel syndrome or another chronic inflammatory disease * Use immunosuppressive medication * Receiving contraceptive hormone therapy * Pregnant * Presence/history of malignancy
References
Publications (0)
Data not yet available