NCT06168097进行中（未招募）不适用
MicroRNAs Dysregulation as Potential Biomarkers for Effective Diagnosis of Endometriosis
Asian Institute of Gastroenterology, India2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年11月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- 2. To understand the function of candidate predictive miRNAs for endometriosis by investigating their downstream targets and associated biological pathways
研究概览
简要总结
OBJECTIVES :
- To investigate the expression pattern of miRNAs operational in inflammation, angiogenesis, hypoxia, apoptosis and cell proliferation in eutopic and ectopic endometrium of patients with endometriosis and normal endometrium of healthy controls.
- To understand the function of candidate predictive miRNAs for endometriosis by investigating their downstream targets and associated biological pathways.
- Evaluation of significant outcome of objective 1 in serum samples to establish them as biomarkers.
Study Design:
Case control study. sample size: 200
详细描述
METHODOLOGY :
1 Investigator will take Both blood and tissue samples used to study them. 2. Investigator will take approximately 3 ml of blood which will be used from the blood sample collected for routine preoperative tests (Surgical profile) before their planned surgery.
3.Small tissue samples will be taken from the tissue which is surgically excised as a part of treatment.
- It will include tissue from inner lining of uterus (endometrium) in all participants and from excised endometriosis tissue in patients with endometriosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients having more severe forms of endometriosis (Stage III and IV)
- •The probands were chosen randomly from the pool of available endometriosis patients and healthy controls of Indian origin.
排除标准
- •Diagnosis of non-endometriotic ovarian cysts, adenomyosis, ovarian cancer, fibroids, and stage I and II endometriosis.
- •Exclusion criteria defined for the control group were personal history of chronic pelvic pain, secondary dysmenorrhea, abnormal uterine bleeding and family history of endometriosis.
结局指标
主要结局
2. To understand the function of candidate predictive miRNAs for endometriosis by investigating their downstream targets and associated biological pathways
时间窗: 3 years
ROC curve analysis is to estimate the sensitivity and specificity of miRNA expression levels to establish them as biomarkers for endometriosis.
次要结局
- To investigate the expression pattern of miRNAs and their downstream targets in endometrial tissues (samples of normal adult endometrium and ectopic and eutopic endometrium of patients with endometriosis)(3 years)
研究者
研究点 (2)
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