Mitochondrial DNA Deletions in Plasma as a Diagnostic Aid for Females Presenting With Symptoms of Endometriosis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Presence or absence of endometriosis
研究概览
简要总结
This study will investigate the clinical performance and diagnostic accuracy of the Mitomic® Endometriosis Test (MET) compared to laparoscopic diagnosis in a prospective clinical study in females presenting with symptoms suggestive of endometriosis. This study will recruit patients with suspected endometriosis who have been referred for a diagnostic laparoscopy. Patients will complete a questionnaire about their endometriosis symptoms and a sample of blood will be taken prior to their laparoscopy and sent to the laboratory for the MET to be run.
This study aims to first enroll 104 subjects to support the clinical validation necessary for launch of the test as an LDT. Following this, we plan a study extension with an aim to enroll up to 900 more (for a total of 1000) subjects to enable more precise estimation of performance characteristics, characterization of test performance in subtypes of endometriosis, to better understand the relationship between test results and secondary endpoints such as symptoms and demographic variables, and to establish a bank of samples to support future test development.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Be female, between menarche and menopause who present with symptoms of endometriosis at time of blood collection and are scheduled to undergo their first laparoscopic procedure for the diagnosis of endometriosis
- •Provide a blood sample prior to surgical procedure or administration of drugs related to the surgical procedure (i.e. anaesthetics, antibiotics)
- •Be fit to undergo all procedures listed in protocol
- •Be able to provide written informed consent
排除标准
- •Has had a prior surgical diagnosis of endometriosis at time of blood collection
- •Is unable to communicate in written and spoken English
- •Has any other condition, which in the opinion of the investigator, would make the subject not a suitable candidate for the study. This reason must be recorded on the CRF
结局指标
主要结局
Presence or absence of endometriosis
时间窗: up to 5 years
Presence or absence of endometriosis as determined by standard-of-care diagnostic laparoscopy
次要结局
未报告次要终点