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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Immune profile.
- Who it may be relevant to
- Registry conditions: Endometriosis, Chronic Pelvic Pain Syndrome. Basic parameters: 18 years — 40 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Other Immune profile
The 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.
Primary outcome measures
- Identify a specific immune profile in patients with chronic pelvic pain, with or without endometriosis, who have failed hormone treatment. [Time frame: 24 months]
Secondary outcome measures (5)
- Identify a specific immune profile in patients with chronic pelvic pain associated with a neuropathic component of pain. [Time frame: 24 months]
- Identify a specific immune profile in patients with chronic pelvic pain associated with pelvic pain sensitization. [Time frame: 24 months]
- Identify a specific immune profile in patients with chronic pelvic pain associated with infertility [Time frame: 24 months]
- Identify a specific immune profile in patients with chronic pelvic pain associated with endometriosis [Time frame: 24 months]
- Identify a specific immune profile in patients with chronic pelvic pain based on symptom severity and the extent of endometriosis lesions on imaging. [Time frame: 24 months]
Eligibility criteria
Inclusion criteria
- Aged between 18 and 40;
- Under continuous hormone treatment for at least 6 months;
- Imaging less than 12 months old: either normal or showing endometriosis and/or adenomyosis lesions, excluding any other abnormalities that could explain the PCOS;
- Affiliation with the French Social Security system;
- Signature of informed consent.
Exclusion criteria
- Pregnant or breastfeeding women;
- Autoimmune disease;
- History of cancer within the last 5 years or currently undergoing treatment;
- Current infectious syndrome;
- Person under guardianship or conservatorship.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
France · 1 center
- CHU Nice - Hôpital de l'Archet 2 — Nice
Identifiers
NCT: NCT07429773 · 25-AOI-07