RECHERCHE DE MARQUEURS DIAGNOSTIQUES ET PRONOSTIQUES DE L'ENDOMETRIOSE DANS LE SANG DES REGLES CHEZ LES FEMMES EN AGE DE PROCREER
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Diagnostic and prognostic score
研究概览
简要总结
The goal of this observational study is to identify diagnostic and prognostic biomarkers for endometriosis using menstrual blood, an easily accessible yet overlooked biological fluid in women of reproductive age, affected or not by endometriosis
The main questions it aims to answer are:
- are there relevant differences in the menstrual blood of women affected by endometriosis compared to women without endometriosis?
- do some of these differences disappear or lessen when the disease is treated by surgery? Participants will answer questions relevant to endometriosis and provide menstrual blood 1 to 3 times (self-collected with a menstrual cup). A subgroup of participants affected by endometriosis that will undergo surgery for their regular care will provide menstrual blood before and after their surgery.
Researchers will compare the menstrual blood of women with and without endometriosis, and before and after surgery to see if they can identify significant differences.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •For all participants:
- •Women 18-45 of age who
- •Have their period
- •Have given their written consent
- •Have already used a menstrual cup as a method of hygienic protection
- •Residing or working in Ile de France (Paris Metropolitan area, France)
- •For participants with endometriosis:
- •diagnosis of endometriosis established by surgery or imaging (ultrasound and/or MRI)
- •presence of one or more painful symptoms > 3 on a visual scale (dysmenorrhea and/or dyspareunia and/or chronic pelvic pain) and/or infertility
- •for the surgery subgroup: planned surgery in the next 3 months
- •For participants without endometriosis:
- •painful symptoms < or equal to 3 on a visual scale (for dysmenorrhea and dyspareunia and chronic pelvic pain),
- •absence of intense period pain in adolescence (leading to taking pills to control this pain and/or peri-menstrual school absenteeism)
排除标准
- •For all participants:
- •Autoimmune diseases
- •Chronic diseases other than endometriosis (diabetes, hypertension)
- •A person who is the subject of a judicial safeguard measure (by declaration)
- •Infectious diseases (HIV, HBV, if known)
- •History of menstrual toxic shock syndrome
- •For patients with endometriosis:
- •endometriosis surgery within the last 3 months.
研究组 & 干预措施
With endometriosis
Women affected by endometriosis
Without endometriosis
Women without any clinical sign of endometriosis
结局指标
主要结局
Diagnostic and prognostic score
时间窗: 3 years and 8 months
Score based on candidate biomarkers that will be selected for their quantitative differences between patients with or without endometriosis and for their prognostic potential in the context of response to surgical treatment (significant quantitative difference between before and after surgery). Biomarkers that are both significantly quantitatively different between women with and without endometriosis and before versus after surgery will constitute the final set and this set will be measured by targeted approach in all the participants. This score, associated or not with clinical characteristics (such as for example the intensity of pain, the association of different types of pain), will make it possible to differentiate women with and without endometriosis with a specificity greater than or equal to 79% and a sensitivity greater than or equal to 94%.
次要结局
- Prognostic candidate score(3 years and 8 months)
- Diagnostic score for a specific subtype of endometriosis(3 years and 8 months)
- Diagnostic score(3 years and 8 months)