Characterization of Immune Cells and Their Secreted Cytokines in Endometriosis Patients

Not yet recruiting

• Conditions: Endometriosis

• Registration Number: NCT06897436
• Lead Sponsor: Medical University of Lublin

Brief Summary

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.

Detailed Description

EUmetriosis will generate new knowledge in the field of endometriosis, its drivers and consequences, as well as biological determinants, which will result in a better understanding of endometriosis pathogenesis and the factors involved. Specifically, the project will assess the role of the immune cells, diet, cognitive behaviour and other related factors in disease pathogenesis, and develop strategies on how to alleviate endometriosis-associated pain, enhance quality of life and improve outcomes for patients. The knowledge base (like the association between nutrition, epigenetics, the microbiome and endometriosis) and methodologies generated within the project will drive the fields of gynaecology, primary care, pain medicine, urology and gastroenterology forward. Finally, through the collection of evidence for effective self-management strategies, the project will pave the path for more patient-tailored health policies. The project aims to link different stakeholder groups involved in this field, like clinicians, patients, healthcare insurers/payers and other researchers in women's health. With this multidisciplinary consortium, EUmetriosis will maximise its impact by creating therapeutic and diagnostic endometriosis solutions best suited to real-world applications, with a clear strategy for implementation.

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-03-14
• Study First Submitted QC: 2025-03-24
• Last Update Submitted: 2025-03-24
• Study First Posted: 2025-03-27
• Last Update Posted: 2025-03-27
• Study Start: 2025-05-01
• Primary Completion: 2029-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Alterations in immune system cell phenotype and activity associated with endometriosis.	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.	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.	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.	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.