Characterization of Immune Cells and Their Secreted Cytokines in Endometriosis Patients

NCT06897436 | Not Yet Recruiting

• 2 other identifiers: 101157146Project 101157146-EUmetriosis
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Endometriosis

Keywords

endometriosis; dermoid cyst; immune system

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

  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.

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The University Clinical Hospital No.4 and No.1, 1 Military Clinical Hospital in Lublin SPZOZ

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Lublin: lead
• European Commission: collaborator

Related Links

• 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.

Biospecimen

Retention: SAMPLES WITH DNA

peripheral blood, menstrual effluent/blood

MeSH Terms

Conditions

Endometriosis; Dermoid Cyst

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Cysts; Neoplasms; Teratoma; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type

Study Officials

• Jarogniew Łuszczki, professor

  UNIWERSYTET MEDYCZNY W LUBLINIE

  STUDY DIRECTOR

Central Study Contacts

Marek Gogacz, professor

CONTACT

marekgogacz@umlub.pl; marekgogacz@umlub.pl

Iwona Wertel, professor

CONTACT

iwonawertel@umlub.pl; iwonawertel@umlub.pl

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: March 14, 2025
• First Posted: March 27, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: March 27, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share