A Double-Blind Observational Study to Validate the SpotitEarly Test for the Detection of Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 500
- 主要终点
- Sensitivity and specifically of the SpotitEarly testing in each of the subgroups
研究概览
简要总结
Primary Objective:
1. To evaluate the sensitivity of the SpotitEarly test for breast cancer detection in women
Secondary Objectives:
- To evaluate the performance of the SpotitEarly in various subgroups.
- To evaluate the performance of the SpotitEarly test in detecting early-stage cancer (stages 0-2).
- To assess whether the performance of the SpotitEarly test is affected by psychological impacts (e.g. anxiety) related to the biopsy procedure.
Exploratory Objective:
1. To evaluate the test-retest reliability of SpotitEarly's test.
详细描述
The goal of this study is to find out whether a system that uses trained detection dogs and artificial intelligence (AI) can identify breast cancer from a person's breath. Women who are scheduled to have screening breast cancer screening, or a biopsy for a possible cancer, will be invited to take part. Participants will be asked to breathe into a surgical mask to collect a breath sample.
The mask will be sent to a special laboratory, where trained dogs and an AI-based system will check the sample for signs of breast cancer. The results from the dogs and AI will be compared to the actual results from the medical screening or biopsy to see how accurate the system is at detecting breast cancer.
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
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Sensitivity and specifically of the SpotitEarly testing in each of the subgroups
时间窗: 12 months
Age: under 40, 40-49, 50-64, 65 and older. Race: White, Black/African American, Asian and Pacific Islander, Native American/ Alaska Native, more than one race. Germline pathogenic variant carriers associated with high risk for breast cancer (BRCA1, BRCA2, PTEN, TP53, CDH1, STK11) versus non-carriers. Smoking status: smokers versus non-smokers. Women with type-2 diabetes versus women who were not diagnosed with the disease.
次要结局
- Sensitivity of the SpotitEarly test in detecting early-stage cancer among breast cancer-positive samples(24 months)
研究者
Brian Englander
Chair of Department of Radiology at Pennsylvania Hospital
Abramson Cancer Center at Penn Medicine