ENDOCHAP Monocentric Cohort: Clinical and Molecular Study of Endometriosis and Adenomyosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5,300
- 试验地点
- 1
- 主要终点
- Pain scores (analog visual scale), quantification of uterine bleeding (number of towels or tampon/day/month) and live birth rates
研究概览
简要总结
The purpose of this study is to determine whether endometriosis and adenomyosis are progressive diseases, in terms of symptoms (pain, abnormal uterine bleeding and infertility), anatomical lesions size, and recurrences. We also aimed to address molecular questions on immune dialogues between ectopic lesions and the eutopic endometrium, auto-immunity in endometriosis and adenomyosis and the role of the microbiota in their respective pathophysiologies.
详细描述
Endometriosis and adenomyosis are benign gynecological conditions which affect more than 10% of women, that typically cause pain and / or infertility, thereby exerting a negative impact on the patients' quality of life.
Although the pathogenesis of endometriosis and adenomyosis are controversial, both diseases are defined by the presence of endometrial tissue outside the uterine cavity. Endometriosis is a heterogeneous disease, with three phenotypes: superficial peritoneal endometriosis (SUP), ovarian endometrioma (OMA), and deep infiltrating endometriosis (DIE) The most widely accepted pathophysiological hypothesis for endometriosis is that of the implantation of ectopic endometrial cells following peritoneal reflux. Endometriosis can be associated with adenomyosis, also heterogeneous, characterized by the infiltration of endometrial tissue into the myometrium, presenting different forms: diffuse, focal or cystic.
Due to diseases heterogeneity, the diagnosis of endometriosis and adenomyosis is difficult and affected patients are subject to a long delay for appropriate management.
We hypothesize that the disease may be progressive in terms of symptoms (pain, abnormal uterine bleeding and infertility), anatomical lesions and recurrences. Furthermore, highlighting specific clinical and molecular markers would shorten the diagnostic time.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women of age between - 18 and 42 years old.
- •In-service care for one of the pelvic pain and/or infertility, or for a pelvic mass.
- •Having a radiological diagnosis made by a referral practitioner and/or operated in the department
排除标准
- •HIV-positive women, HBV and HCV
- •During pregnancy
- •Having a cancer diagnosis
- •Refusing to sign a consent.
研究组 & 干预措施
Patient with benign gynaecologic disease
Patients consulting for endometriosis, pelvic pain, abnormal uterine bleeding and/or infertility, or for a pelvic mass,
干预措施: Biological/Vaccine (Biological)
结局指标
主要结局
Pain scores (analog visual scale), quantification of uterine bleeding (number of towels or tampon/day/month) and live birth rates
时间窗: 10 years
Composite outcome
Changes in lesions or recurrences to imaging performed during the gynaecological follow-up of the patient
时间窗: 10 years
次要结局
- Association between clinical parameters of interrogation and clinical examination and the presence of endometriosis.(10 years)
- Metabolic pathway exploration in adenomyosis lesions(10 years)
- To study the natural history of deep endometriosis lesions and analysis of focused invasion processes, epithelio-mesenchymatous transitions, and fibrogenesis using molecular biology techniques(10 years)
- Characterization of the microbiota in urine and vaginal samples.(10 years)
- Association between clinical data and the occurrence of the disease(10 years)
- Delays between the onset of symptoms and post-operative or radiological histological diagnosis with specialized imaging (transvaginal ultrasound, endorectal ultrasound, magnetic resonance imagingI(10 years)
- meeting specific criteria for endometriosis and adenomyosis lesions(10 years)
- Serum dosage of circulating antibodies before and after surgical treatment of lesions(10 years)
- Creating a score on clinical diagnosis(10 years)
- Establish a genotype/phenotype correlation of the disease (endometriosis and adenomyosis)(10 years)
- Pain scores (analog visual scale), quantification of uterine bleeding (number of towels or tampon/day/month) and live birth rates(7 years)
- Association between clinical parameters of interrogation and clinical examination and the presence of adenomyosis.(10 years)
- - Evaluation of individualized management: comparison between different management strategies on pain scores (analog visual scale), pregnancy-conception desire delay, live birth rate(10 years)
- Study of the presence of autoantibodies in cases of endometriosis and adenomyosis(10 years)