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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorCentre Hospitalier Universitaire de Nice

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

Pregnant or breastfeeding women;

Autoimmune disease;

History of cancer within the last 5 years or currently undergoing treatment;

Current infectious syndrome;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Immune profile

    Other intervention

    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.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Group 1 : Patients with pelvic painExperimental treatment 1 intervention
Group B: Group 2 : Asymptomatic patientsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Identify a specific immune profile in patients with chronic pelvic pain, with or without endometriosis, who have failed hormone treatment.

Measurement of 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.

Time frame
24 months

Secondary outcomes

1

Identify a specific immune profile in patients with chronic pelvic pain associated with a neuropathic component of pain.

As before, the immune profile will be determined by measuring the blood concentrations (in pg/mL) of pro-inflammatory and anti-inflammatory cytokines after non-specific stimulation of peripheral blood cells : IL4, IL5, IL12p70, 1L17A, IFNγ, IL1β, IL6, IL8, IL10, IL15, IL18, TNFα, TGFβ. We will then make comparison between the immune profiles of patients with chronic pelvic pain, whether or not associated with a DN4 score ≥4/10.

Time frame
24 months
2

Identify a specific immune profile in patients with chronic pelvic pain associated with pelvic pain sensitization.

The immune profile will be determined by measuring the blood concentrations (in pg/mL) of pro-inflammatory and anti-inflammatory cytokines after non-specific stimulation of peripheral blood cells : IL4, IL5, IL12p70, 1L17A, IFNγ, IL1β, IL6, IL8, IL10, IL15, IL18, TNFα, TGFβ. We will then make comparisons between the different profiles studied: Compare the immune profiles of patients with chronic pelvic pain, whether or not associated with a Convergence PP score ≥ 5/10.

Time frame
24 months
3

Identify a specific immune profile in patients with chronic pelvic pain associated with infertility

The immune profile will be determined by measuring the blood concentrations (in pg/mL) of pro-inflammatory and anti-inflammatory cytokines after non-specific stimulation of peripheral blood cells : IL4, IL5, IL12p70, 1L17A, IFNγ, IL1β, IL6, IL8, IL10, IL15, IL18, TNFα, TGFβ. . We will then make comparison between the different profiles studied: Compare the immune profiles of patients with chronic pelvic pain, with or without clinical infertility (no pregnancy after 12 months of unprotected intercourse).

Time frame
24 months
4

Identify a specific immune profile in patients with chronic pelvic pain associated with endometriosis

The immune profile will be determined by measuring the blood concentrations (in pg/mL) of pro-inflammatory and anti-inflammatory cytokines after non-specific stimulation of peripheral blood cells : IL4, IL5, IL12p70, 1L17A, IFNγ, IL1β, IL6, IL8, IL10, IL15, IL18, TNFα, TGFβ. We will then make comparison between the immune profiles of patients with chronic pelvic pain, whether or not associated with endometriosis confirmed by imaging at a reference center (according to compliance with the positivity criteria of the protocol and the French ENDOVALIRM reference system (to characterize deep lesions on MRI) and/or the ESUR 2017 reference system (for ovarian lesions) and/or the SUR-US 2024 reference system (for ultrasound)).

Time frame
24 months

Other outcomes

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