Evaluation of Genetic Signature in Endometriosis Disease by Non Invasive Sampling
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Wet lab kit validation
研究概览
简要总结
Endometriosis is a disease that affects 10-15% of the general population and 50% of infertile women. It is characterized by the presence of endometrial tissue outside the uterine cavity. Endometriosis can lead to infertility by interfering through endocrine and mechanical alterations on the function of the ovaries, fallopian tubes, and uterus. The aim of the study is to define the differential expression of a cluster of RNAs tissue driven for the identification of an RNA profile in saliva, specific for endometriosis. This study focuses on the expression of genes involved in the control and regulation of apoptosis, cell survival, metabolism, cell adhesion and invasion, angiogenesis, inflammation, and estrogen receptor expression levels.
详细描述
Retrospective selection based on anamnestic criteria of: 50 patients with diagnosed endometriotic adnexal pathology (case, CA), 50 patients with non-endometriotic adnexal pathology (control, CO) and 50 patients with no gynecological pathology, not undergoing surgery (analytical control).
The study involves collecting a saliva sample from all patients involved in the study, and performing a biopsy from both patients with endometriotic adnexal pathology (CA) and patients with non-endometriotic adnexal pathology (CO).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
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
- •Case population (CA), patients with endometriotic adnexal pathology
- •Control population (CO), patients with non-endometriotic adnexal pathology
- •Analytical control population (C-), patients with no gynecologic pathology, not undergoing surgery
排除标准
- •Women with ages outside the inclusion range
- •Pregnant patient
- •Patient with a personal history of cancer
- •Patient infected with HIV
结局指标
主要结局
Wet lab kit validation
时间窗: 1 month
Assessing the quality of the kit by mapping the reads against public miRNA databases. Following benchmark will be considered: Total reads mapped \[integer\]
Next Generation Sequencing technical validation
时间窗: 1 month
Assessing the quality of Next Generation Sequencing via the FASTQC tool. Following benchmarks will be considered: 1.1 Per base sequence quality \[Phred score: positive real number, the higher the better\] 1.2 Total number of sequenced reads \[integer: positiver integer number, the higher the better\]
次要结局
- Tissue validation(2 months)
- Clinical validation(4 months)
- Biomarkers identification(7 months)