Development and Evaluation of RNA-based Markers for Detecting and Diagnosing Endometriosis
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Develop a gene signature that detects endometriosis
研究概览
简要总结
Endometriosis is a common disease that affects up to 10% of women of reproductive age. Diagnosis, however, is typically delayed (up to 12 years) and is usually made after surgery. A key unmet need therefore is an accurate biomarker that can be used to detect the disease early. This study is a prospective trial to identify candidate mRNA-markers which can be used to aid in the diagnosis of this disease. It is a discovery/validation study that will identify and confirm a gene expression panel that is specific for endometriosis and provides a non-invasive tool for future use.
详细描述
Endometriosis is a common disease that affects up to 10% of women of reproductive age. Diagnosis, however, is typically delayed (up to 12 years) and is typically made after surgery. A key unmet need therefore is an accurate, non-invasive biomarker that can be used to detect the disease early.
We hypothesize that endometriosis-related circulating gene expression can be identified using transcriptomic and bioinformatics approaches and used to construct an accurate diagnostic tool for this condition.
The primary objective is to develop a gene signature that detects endometriosis. The hypothesis is that this disease is characterized by a set of genes that characterize endometriosis tumor biology.
The aim is to detect over-expressed genes (elevated mRNA expression) in endometriosis tissue. The goal is to identify 10-25 biomarker genes that are highly expressed to form a candidate biomarker panel.
Highly expressed genes will be determined against samples collected from age/menstrual stage matched controls. A bio-informatics approach will be used to identify these over-expressed genes. This form the basis of a potential diagnostic panel.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •For the endometriosis cohort
- •a history of infertility more than 1 year
- •age 20-35 years
- •normal liver and kidney function, without gynaecological and other systemic disease
- •Inclusion criteria for controls include normo-ovulatory history, aged between 20-35 years, who exhibit normal liver and kidney function, and do not have any systemic diseases including autoimmune disease.
排除标准
- •For the endometriosis cohort
- •polycystic ovary syndrome, hyperprolactinemia
- •severe cardiovascular system, liver, kidney, and hematopoietic system disease
- •autoimmune disease
- •uterine fibroids, endometritis, non-vegetative ovarian cysts, ovarian malignancies, and internal genital tuberculosis
- •Exclusion criteria for the controls includes gynaecological malignancies and genital tuberculosis.
结局指标
主要结局
Develop a gene signature that detects endometriosis
时间窗: 12-18 months
Gene expression levels in samples from endometriosis subjects and controls
次要结局
- Assess the diagnostic utility of the gene signature to differentiate between endometriosis and controls(6 months)