"EUmetriosis: Transforming Endometriosis Care in Europe: an Integrated Approach to Enhance Understanding, Diagnosis, Tailored Management and Patient Empowerment
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Alterations in immune system cell phenotype and activity associated with endometriosis.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
- •Presence/history of malignancy
结局指标
主要结局
Alterations in immune system cell phenotype and activity associated with endometriosis.
时间窗: 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.
时间窗: 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.
次要结局
未报告次要终点
研究者
Iwona Wertel
professor
Medical University of Lublin