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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 : Patients with pelvic pain | Experimental | Patients with chronic pelvic pain resistant to hormone therapy |
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| Group 2 : Asymptomatic patients | Experimental | Asymptomatic patients undergoing hormone therapy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immune profile | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pierre-Alexis GAUCI, MD | Contact | 04 92 03 61 90 | +33 | gauci.pa@chu-nice.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Nice - Hôpital de l'Archet 2 | Nice | Alpes-Maritimes | 06200 | France |
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| 24 months |
| 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. | 24 months |
| 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). | 24 months |
| 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)). | 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. | 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 in the context of endometriosis, according to the location of the lesions (ovarian, deep or superficial). | 24 months |
| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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