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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Identify a specific immune profile in patients with chronic pelvic pain, with or without endometriosis, who have failed hormone treatment.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Group 2 : Asymptomatic patients
Asymptomatic patients undergoing hormone therapy
干预措施: Immune profile (Other)
Group 1 : Patients with pelvic pain
Patients with chronic pelvic pain resistant to hormone therapy
干预措施: Immune profile (Other)
结局指标
主要结局
Identify a specific immune profile in patients with chronic pelvic pain, with or without endometriosis, who have failed hormone treatment.
时间窗: 24 months
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.
次要结局
- Identify a specific immune profile in patients with chronic pelvic pain associated with a neuropathic component of pain.(24 months)
- Identify a specific immune profile in patients with chronic pelvic pain associated with pelvic pain sensitization.(24 months)
- Identify a specific immune profile in patients with chronic pelvic pain associated with infertility(24 months)
- Identify a specific immune profile in patients with chronic pelvic pain associated with endometriosis(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.(24 months)