A Double Blind Observational Study to Validate the SpotitEarly Test for the Detection of Breast Cancer (The PINK Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,204
- 试验地点
- 7
- 主要终点
- Test Performance Evaluation
研究概览
简要总结
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 routine breast cancer screening, such as a mammogram, ultrasound, 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
- •FOR ARM 1 (TARGET POPULATION ARM)
- •Capable of giving informed consent for self, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- •Assigned female at birth.
- •40 years of age and above OR
- •Between 18 and 39 years of age (inclusive) and a carrier of germline pathogenic variants associated with high risk for breast cancer: BRCA1, BRCA2, PTEN, TP53, CDH1, or STK11 ATM, CHEK2, BARD1, RAD51D, RAD51C, PALB2, OR
- •Between 18 and 39 years of age (inclusive) with a family history of breast or ovarian cancer involving at least one first or two second-degree relatives who were diagnosed with breast or ovarian cancer before the age of 50 years.
- •Scheduled for routine annual breast cancer screening (Mammogram, Ultrasound and MRI)
- •INCLUSION CRITERIA FOR ARM 2 (ENRICHED ARM)
- •Capable of giving informed consent for self, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
- •Assigned female at birth.
- •40 years of age and above. OR
- •Between 18 and 39 years of age (inclusive) and a carrier of germline pathogenic variants associated with high risk for breast cancer: BRCA1, BRCA2, PTEN, TP53, CDH1, or STK11 ATM, CHEK2, BARD1, RAD51D, RAD51C, PTEN , PALB2 OR
- •Between 18 and 30 years of age (inclusive) with a family history of breast or ovarian cancer involving at least one first or two second-degree relatives who were diagnosed with breast or ovarian cancer before the age of 35 years.
- •BI-RADS® score of 4B.
- •Scheduled for breast biopsy.
排除标准
- •(BOTH STUDY ARMS)
- •Had cancer within the past year. Individuals who underwent surgical removal of cancerous non-metastatic skin lesions can be recruited.
- •Has received any cancer treatments within the past year.
- •Has participated in another clinical study in the past 30 days.
- •Had bilateral mastectomy for breast cancer or for preventive reasons related to breast cancer.
- •Had a medical procedure in the chest cavity and/or airways within the past 2 weeks which may interfere with the ability to provide a normal breath sample as required by the protocol.
研究组 & 干预措施
Target Population Arm
Women scheduled for routine breast cancer screening by mammography/ultrasound/magnetic resonance imaging
干预措施: Breath test (Diagnostic Test)
Enriched Arm
Women scheduled for breast biopsy with a Breast Imaging and Reporting Data System (BI-RADS®) score of 4B or above
干预措施: Breath test (Diagnostic Test)
结局指标
主要结局
Test Performance Evaluation
时间窗: 24 months
The test performance will be determined by analysis of the sensitivity and the specificity of the primary endpoint sample set, where sensitivity is the number of participants with a true positive result divided by the number of participants with a positive clinical diagnosis (positive biopsy), and specificity is the number of participants with a true negative result divided by the number of participants with a negative clinical diagnosis.
次要结局
- Test Performance Evaluation in different subgroups(24 months)
- Test Performance in early-stage cancer(24 months)
- Test Performance in the clinic vs. at patients' home(24 months)
- Effect of psychological impacts on performance in the enriched arm(12 months)