NCT04728152Unknown不适用
Evaluation of miRNAs in Endometriosis
Groupe expert en endometriose-6 centre expert en endometriose1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年1月27日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Describe the evolution of miRNA expression (blood and salivary)
研究概览
简要总结
We therefore propose a research project based on the prospective evaluation of miRNAs (blood and salivary) in patients with endometriosis diagnosed (by clinical examination and imaging) or suspected of endometriosis (clinical/radiological discordance) and in need of management in routine care (surgical or medical PMA) in the Endometriosis Expert Center Hospital.
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 43 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient aged 18 to 43 years old,
- •Patient has dated and signed the consent form,
- •Patient affiliated with the French health care system,
- •Patients with formal endometriosis diagnosed by clinical examination and imaging or suspicion of endometriosis for which the diagnosis is a source of discrepancy between clinical and radiological data,
- •Patient with an indication for medically assisted procreation (MAP) or surgery validated in CPR (in routine care),
- •Patient who has had a pelvic MRI,
- •Patient who completed the symptom and quality of life questionnaires
排除标准
- •Pregnant patient,
- •Patient infected with the human immunodeficiency virus (HIV),
- •Patient with significant difficulties in reading or writing the French language,
- •Patient with a personal history of cancer,
- •Patient unable to comply with study and/or follow-up procedures,
- •Patient who has objected to the collection of her data.
- •Patient participating in another clinical research study.
结局指标
主要结局
Describe the evolution of miRNA expression (blood and salivary)
时间窗: 1 month
次要结局
- To quantify the reproducibility of salivary miRNA expression over time (between the inclusion visit and the pre-therapy visit) ;(1 month)
- To describe (quantitatively and qualitatively) the expression of blood and salivary miRNAs in patients with suspected or actual endometriosis;(1 time)
- Describe the expression of miRNAs (blood and salivary) according to the presence or absence of endometriosis and according to the endometriosis phenotype ;(1 time)
- Describe the relationship between miRNA expression (blood and salivary) and the level of ovarian reserve, as estimated by the AMH assay in patients of childbearing age ;(1 time)
研究者
Sofiane Bendifallah
MD, PhD
Groupe expert en endometriose-6 centre expert en endometriose
研究点 (1)
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