Non-Invasive Identification of Endometrial Cancer/Endometrial Atypical Hyperplasia With an AI-Based Classifier Applied to Transvaginal Ultrasound in Patients With Post-Menopausal Bleeding
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 300
- 试验地点
- 3
- 主要终点
- Accuracy of artificial intelligence (AI) algorithm applied to transvaginal ultrasound (TVUS)
研究概览
简要总结
This study evaluates if AI can be used with transvaginal ultrasound images for early detection of endometrial cancer or premalignant lesions.
详细描述
PRIMARY OBJECTIVE:
I. Prospective validation of an artificial intelligence (AI) algorithm applied to transvaginal ultrasound (TVUS) to identify patients with premalignant/malignant in a population of women with postmenopausal bleeding (PMB).
OUTLINE: This is an observational study.
Patients undergo a transvaginal ultrasound examination and endometrial sampling per standard of care and have their medical records reviewed on study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 55 years
- •At least one episode of postmenopausal bleeding (PMB)
- •Endometrial biopsy available from at Mayo Clinic (MN, AZ, FL), Mayo Clinic Health System (MCHS), or an external institution
- •Acceptance to participate in the study
排除标准
- •Diagnostic tests performed more than 90 days apart
- •Physical impediment/refusal to undergo transvaginal ultrasound (TVUS)
研究组 & 干预措施
Observational
Patients undergo a transvaginal ultrasound examination and endometrial sampling per standard of care and have their medical records reviewed on study.
干预措施: Non-Interventional Study (Other)
结局指标
主要结局
Accuracy of artificial intelligence (AI) algorithm applied to transvaginal ultrasound (TVUS)
时间窗: Baseline
Two static TVUS images (one longitudinal, one transversal) will be independently validated and compared to results of endometrial sampling. Outcomes from these will be compared with predictions made by the AI models for accuracy of assessing premalignant/malignant disease.
次要结局
未报告次要终点