Endometrial Cancer Cell Collection With the Preprogen PadKit™
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Observation of the presence of endometrial cells captured by the pad.
研究概览
简要总结
All patients will be provided with a Preprogen Pad to be worn for 4-6 hours to collect cells shed by the endometrium. After the kit is returned to the Preprogen laboratory, a brief survey will be completed. Analysis will be conducted to determine if the PadKit™ can collect a sample of endometrial cells sufficient to differentiate between normal and atypical hyperplasia/malignant cells in blinded samples provided to the laboratory for analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
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
- •1. Women who present to Gynecologic Oncology for surgical intervention and have not undergone prior hysterectomy.
- •Cohort 1: has biopsy proven atypical hyperplasia or endometrial cancer.
- •Cohort 2: women with planned hysterectomy for benign clinical indications
排除标准
- •Unable to provide informed consent
- •Women who have previously undergone uterine surgery (subtotal, or supracervical hysterectomy).
研究组 & 干预措施
Biopsy proven hyperplasia/endometrial cancer with planned hysterectomy
Women with biopsy proven hyperplasia/endometrial cancer with planned hysterectomy
干预措施: PadKit™ from Preprogen (Device)
Benign clinical indications
Women with planned hysterectomy for benign clinical indications
干预措施: PadKit™ from Preprogen (Device)
结局指标
主要结局
Observation of the presence of endometrial cells captured by the pad.
时间窗: Within 7 days after receipt of the pad from patients
Direct observation of the absence or presence of endometrial cells on the pad by the pathologist
Association of the presence/absence of cells and morphology
时间窗: Within 7 days after receipt of the pad from patients
Analysis for the presence of abnormal histology and morphological classification as normal, hyperplastic, or malignant.
次要结局
- Patient preferences - Comfort(Within the same day and after wearing the pad for 4-6 hours)
- Patient preferences - Simplicity of using the pad(Within the same day and after wearing the pad for 4-6 hours)