Developing a Complex ex Vivo Endometrial Tissue Model Based on Patient Biopsies to Assess and Optimise the Response to Current and Potential Treatments for Endometriosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Viability of all the cells forming the complex endometrial tissue generated ex vivo by tissue bioengineering.
研究概览
简要总结
Endometriosis is a chronic gynaecological disease characterised by the growth of endometrium outside the uterus. It affects 10% of childbearing age women.
There is no cure for endometriosis. Hormonal treatments should be the first line therapy. The benefit-risk ratio of symptomatic treatment with hormone therapy varies greatly from one woman to another. The pathophysiology of endometriosis and the mechanisms of action of these treatments are still poorly understood. This may be due to the lack of an optimal experimental model for studying the disease.
The aim of this project is to develop a complex ex vivo endometrial model recapitulating the organisation and properties of the human endometrium using innovative tissue bioengineering methods. This model will make it possible to develop a pre-clinical approach that predicts individual response to different types of hormonal treatment in order to optimise therapeutic choices and provide a better understanding of the effects of these treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •People aged between 18 and 50
- •Person who has or has had hormonal contraceptive treatment
- •A person who has given written consent
- •Person diagnosed with a benign gynaecological pathology not affecting the endometrium and requiring hysterectomy, hysteroscopy or laparoscopy or with a diagnosis of endometriosis and requiring laparoscopy or hysterectomy
- •Person affiliated to the french social security
排除标准
- •Pregnant at the time of sampling or within 3 months prior to sampling
- •Breast-feeding women
- •Women undergoing physiological menopause
- •Anyone who has received hormonal treatment with hormones other than steroids in the three months prior to sampling
- •Anyone with a non-hormonal contraceptive intrauterine device (copper coil)
- •Anyone with a personal history of cancer of the breast, ovary, endometrium or cervix
- •People with Lynch syndrome
- •Persons under legal protection (guardianship, curatorship)
- •Persons deprived of their liberty by judicial or administrative decision
- •Persons with a body mass index (BMI) of less than 18.5 or more than 30
研究组 & 干预措施
Endometriosis
Women with endometriosis who have an indication for gynaecological surgery
干预措施: Tissue collection (Procedure)
Endometriosis
Women with endometriosis who have an indication for gynaecological surgery
干预措施: Data collection (Other)
Control
Women with no endometrial pathology who have an indication for gynaecological surgery
干预措施: Tissue collection (Procedure)
Control
Women with no endometrial pathology who have an indication for gynaecological surgery
干预措施: Data collection (Other)
结局指标
主要结局
Viability of all the cells forming the complex endometrial tissue generated ex vivo by tissue bioengineering.
时间窗: through study completion, an average of 18 months
The viability of all the cells forming the complex endometrial tissue generated ex vivo by tissue bioengineering will be assessed either by flow cytometry (labelling with propidium iodide or 7-AAD) or by immunofluorescence (with lipophilic carbocyanine dyes). The scientists involved in the project reserve the right to modify these labelling techniques and the markers mentioned, depending on the technical and logistical challenges encountered during the tissue bioengineering stages.
次要结局
- Change in protein expression(through study completion, an average of 18 months)
- Change in gene expression(through study completion, an average of 18 months)
- Change in inflammation(through study completion, an average of 18 months)
- Steroid hormones in peritoneal fluid(At baseline)
- Change in tissue elasticity(through study completion, an average of 18 months)
- Change in steroid hormone physiology(At baseline)
- Change in histological tissue structure(through study completion, an average of 18 months)