Multicenter Studie Zur Diagnostischen Validierung Eines Labortests Zur Endometriose-Diagnose
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 8
- 主要终点
- Diagnostic Accuracy of the Menstrual Blood-Based Biomarker Test for Endometriosis
研究概览
简要总结
Endometriosis affects at least 1 in 10 women worldwide and is associated with a diagnostic delay of 5-10 years. Currently, definitive diagnosis requires invasive laparoscopy, which is costly and burdensome for patients.
This multicenter diagnostic validation study investigates a non-invasive laboratory test for the diagnosis of endometriosis based on the analysis of biomarkers from menstrual blood samples.
Study Objective:
The primary objective is to evaluate the diagnostic accuracy of a laboratory protocol for biomarker analysis from menstrual blood samples. Performance metrics including Area Under the Curve (AUC), sensitivity, specificity, negative predictive value (NPV), positive predictive value (PPV), positive likelihood ratio (LR+), and negative likelihood ratio (LR-) will be assessed by comparing women with confirmed endometriosis to confirmed controls.
Study Design:
This is a prospective multicenter diagnostic study. Menstrual blood samples are self-collected by participants.
Participants:
A total of 200 menstruating women aged 14-49 years will be enrolled across study sites. Participants are allocated to one of two cohorts.
Study Sites:
The study is conducted at multiple gynecological centers in Austria and Germany, with planned expansion to additional sites.
Sponsor: Diamens FlexCo, Linz, Austria
Expected Study Duration: 3 years
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
- 14 Years 至 49 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged 14 to 49
- •Menstruating
- •Endometriosis group
- •Histologically confirmed endometriosis
- •Imaging-verified endometriosis
- •Laparoscopy-negative group:
- •- Laparoscopy with no evidence of endometriosis
- •Imaging-negative group:
- •Healthy women (no symptoms of endometriosis)
- •Imaging shows no evidence of endometriosis
排除标准
- •Amenorrhea
- •Pregnancy
- •Oncological diseases
- •Use of GnRH agonists or antagonists
研究组 & 干预措施
Controls
Laparoscopy-Negative Control Cohort: Menstruating women aged 14-49 years in whom endometriosis was excluded by laparoscopy (no visible endometriosis lesions and/or histological exclusion).
Imaging-Negative Control Cohort: Healthy menstruating women aged 14-49 years without known symptoms suggestive of endometriosis, in whom endometriosis was excluded by expert ultrasound or MRI.
Endometriosis
Menstruating women aged 14-49 years with confirmed endometriosis, either laparoscopically/histologically verified or imaging-verified (ultrasound or MRI by an expert).
结局指标
主要结局
Diagnostic Accuracy of the Menstrual Blood-Based Biomarker Test for Endometriosis
时间窗: Single self-collected menstrual blood sampling within 7 months after enrollment.
Area Under the Receiver Operating Characteristic Curve (AUC-ROC) of biomarkers from menstrual blood samples.
次要结局
未报告次要终点