Development of a Molecular Diagnostic Tool for Endometrial Cancer.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,950
- 试验地点
- 26
- 主要终点
- Regulatory Requirements Study
研究概览
简要总结
WomEC is an in vitro diagnostic test for Endometrial Cancer (EC) based on the detection of the expression level of a combination of 5 proteins in the soluble fraction of a pipelle biopsy specimen. The aim of the study consists in validating WomEC's ELISA test, creating and freezing an algorithm to rule out EC in post-menopausal women with abnormal uterine bleeding (AUB).
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Post-menopausal women (≥1 year without menstruation) with AUB who present with:
- •Endometrium > 3mm by transvaginal ultrasound, OR
- •Endometrium ≤ 3mm who meet at least one of the following criteria:
- •i. Persistent symptoms (more than one episode of metrorrhagia) ii. Heterogenous endometrium on transvaginal ultrasonography iii. Risk factors (BMI ≥ 30, use of tamoxifen, hormone replacement therapy (HRT), Lynch syndrome, BRCA mutation.
- •Obtaining written informed consent
排除标准
- •Women with an active pelvic infection.
- •Women who have had viral infections with evidence of active and latent disease such as Hepatitis B, Hepatitis C, and HIV infection. Patients who have had Hepatitis C in the past but who have been successfully treated and in whom viral replication has not been observed in the last year will be included.
结局指标
主要结局
Regulatory Requirements Study
时间窗: 12 months
Ensure the stability of the samples under defined conditions (pre-analytica) and the analytical validation of the developed WomEC's ELISA test.
Algorithm testing and freeze
时间窗: 12 months
To test and freeze the defined algorithm measured with MiMARK's antibodies to rule out EC in post-menopausal women with AUB.
Algorithm training with Proprietary Antibodies
时间窗: 12 months
Train the current WomEC's algorithms defined in MS by assessing the clinical performance of different EC biomarkers individually and in combination to rule out EC in post- menopausal women with AUB using MiMARK's proprietary antibodies.
次要结局
- Evaluation of the performance of WomEC to determine other prognostic factors of EC.(12 months)
- To determine the accuracy of WomEC alone for the diagnosis of EC by pipelle biopsy.(12 months)
- Evaluation of the performance of different models of WomEC to determine histological subtype.(12 months)
- Evaluation of the performance of WomEC to diagnose endometrial atypical hyperplasia.(12 months)