EndometriosisEUmetriosisNCT06897436
Characterization of Immune Cells and Their Secreted Cytokines in Endometriosis Patients
An observational study of Endometriosis, run by Medical University of Lublin.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometriosis
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2025to 31 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The University Clinical Hospital No.4 and No.1, 1 Military Clinical Hospital in Lublin SPZOZ
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Receiving contraceptive hormone therapy
- Pregnant
- Presence/history of malignancy
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: "EUmetriosis: Transforming Endometriosis Care in Europe: an Integrated Approach to Enhance Understanding, Diagnosis, Tailored Management and Patient Empowerment
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.
Read the 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.
- Conditions
- Endometriosis
- Keywords
- endometriosis, dermoid cyst, immune system
- Medical subject headings
- Endometriosis, Dermoid Cyst
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| study group | 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2025
- Study start1 May 2025 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Lublin
- Sponsor type
- University, hospital or other
- Collaborators
- European Commission
- Responsible party
- Principal investigator, Iwona Wertel, Medical University of Lublin
- Investigators
- Jarogniew Łuszczki, professor, Study director, UNIWERSYTET MEDYCZNY W LUBLINIE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06897436
- Sponsor's protocol ID
- 101157146
- Other IDs
- Project 101157146-EUmetriosis
- Acronym
- EUmetriosis
- Status last verified
- Jan 2025
- First submitted
- 14 Mar 2025
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "EUmetriosis: Transforming Endometriosis Care in Europe: an Integrated Approach to Enhance Understanding, Diagnosis, Tailored Management and Patient Empowerment
- ClinicalTrials.gov ID
- NCT06897436
- Acronym / sponsor ID
- EUmetriosis / 101157146
- Conditions
- Endometriosis
- Keywords
- endometriosis, dermoid cyst, immune system
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Medical University of LublinUniversity, hospital or other
- Collaborators
- European Commission
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 27 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | – | –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 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The University Clinical Hospital No.4 and No.1, 1 Military Clinical Hospital in Lublin SPZOZ
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Alterations in immune system cell phenotype and activity associated with endometriosis.
Time frame: 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.
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- CORDIS belongs to the Research and Innovation community platform of the European Commission and complements the Funding and tender opportunities website, where there is possibility to apply for funding and search for partners.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jarogniew Łuszczki, professor study director
UNIWERSYTET MEDYCZNY W LUBLINIE
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis, run by Medical University of Lublin.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marek Gogacz, professor (marekgogacz@umlub.pl, marekgogacz@umlub.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alterations in immune system cell phenotype and activity associated with endometriosis. (time frame: 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.