Endometriosis Diagnosis Using MicroRNA: Prospective Study in Women to Allow Early Disease Recognition
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 750
- 主要终点
- Clinical validity
研究概览
简要总结
Endometriosis is a complex, heterogeneous disease that may present inconsistently across women. Using disease-specific biomarkers and advanced biostatistics, DotLab is developing a biomarker test to confirm the presence of endometriosis.This is a multi-center, prospective, observational, minimal risk study in women undergoing laparoscopy, laparotomy or other pelvic surgical procedure for endometriosis, infertility or another benign gynecological indication. Participants will undergo 2 study visits for collection of blood and saliva and completion of study questionnaires.
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 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participant is willing and able to provide written informed consent.
- •Participant is willing and able to provide up to 50 mL of blood via venipuncture and comply with all other study and sample collection procedures.
- •Participant is a female aged 18 through 49 years (inclusive).
- •Participant is scheduled to undergo:
- •Laparotomy or laparoscopy for signs and symptoms of suspected endometriosis. This shall constitute approximately 95% of the participants enrolled.
- •Laparotomy, laparoscopy, or other procedures including, but not limited to, tubal ligation, lysis of adhesions, hysterectomy for benign condition, myomectomy, salpingo-oophorectomy, cystectomy, or diagnostic laparoscopy for indications including, but not limited to, infertility or benign gynecological indications (e.g., benign pelvic masses, infertility, abnormal uterine bleeding). This shall constitute approximately 5% of the participants enrolled.
排除标准
- •Participant has a history of surgically determined diagnosis of endometriosis (either via visual inspection or histopathology).
- •Participant is a female in a pre-menarchal or post-menopausal state (last menstrual period at least 1 year before Screening and no other biological or physiological cause can be identified) or has been rendered surgically menopausal (bilateral oophorectomy) for at least 6 months at Screening.
- •Participant is pregnant.
- •Participant has an active malignancy.
- •Participant is known to have tested positive for human immunodeficiency virus or hepatitis A, B, or C.
- •Participant has an active pelvic infection or other infections contraindicated for surgery.
- •Participant has participated (±3 months of study enrollment) in a clinical trial where an investigational drug was or is planned to be administered.
- •Participant has any general health or behavioral condition that, in the opinion of the investigator, should exclude the participant from participation.
结局指标
主要结局
Clinical validity
时间窗: From date of first sample collection to surgery, up to 3 weeks
Performance of a microRNA (miRNA)-based assay compared to visual inspection during surgery for the diagnosis of active endometriosis
次要结局
未报告次要终点