Identify a Specific Immune Profile in Patients With Chronic Pelvic Pain Resistant to First-line Treatments by Measuring Th1, Th2, Th17, and Treg Cytokines Produced After Non-specific Functional Cell Stimulation - ImmunoCPP
- Sponsor
- Centre Hospitalier Universitaire de Nice
- Study ID
- NCT07429773
- Status
- Not Yet Recruiting
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Conditions
- Chronic Pelvic Pain Syndrome
- Endometriosis
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - 40 Years
- Healthy Volunteers
- Not accepted
Interventions
- Immune profile — OTHERThe immune profile will be determined by measuring blood concentrations (in pg/mL) of pro-inflammatory and anti-inflammatory cytokines measured after non-specific stimulation of peripheral blood cells from each patient: IL4, IL5, IL12p70, 1L17A, IFNγ, IL1β, IL6, IL8, IL10, IL15, IL18, TNFα, TGFβ.
Study Details
Chronic pelvic pain (CPP) affects more than one in four women. An immune imbalance in the Th1/Th2 balance has been reported in multiple CPP situations, particularly in patients with endometriosis, but with mixed results. The use of a functional immune test, already validated in previous indications and particularly in infertility, could simulate an immune stimulation similar to that of painful attacks.
Key Dates
- First listed
- Feb 24, 2026
- Start date
- Apr 30, 2026
- Status verified
- Jan 2026
- Primary completion
- Apr 30, 2028
- Completion
- Apr 30, 2028
Study Design
- Enrollment
- 120 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- PREVENTION
Arms
- Experimental: Group 1 : Patients with pelvic painPatients with chronic pelvic pain resistant to hormone therapy
- Experimental: Group 2 : Asymptomatic patientsAsymptomatic patients undergoing hormone therapy
Primary Outcome Measure
Identify a specific immune profile in patients with chronic pelvic pain, with or without endometriosis, who have failed hormone treatment. [ Time Frame: 24 months ]
Central Contacts
- Pierre-Alexis GAUCI, MD04 92 03 61 90
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