A Double Blind Observational Study to Validate the SpotitEarly Test for the Detection of Breast Cancer (The PINK Study)
SpotitEarly
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- Yes
INCLUSION CRITERIA FOR ARM 1 (TARGET POPULATION ARM) 1. 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. 2. Assigned female at birth. 3. 40 years of age and above OR 4. 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 5. Between 18 and 39 years of age (inclusive) with a family history of breast or ovar…
Interventions
- Diagnostic TestBreath test
Breath sample collection using a sample collection kit
Locations (5)
- Hackensack Meridian HealthTotowa, New Jersey
- Rambam Health Care CampusHaifa
- Sheba Medical CenterRamat Gan
- Assuta Medical CentersTel Aviv
- Tel Aviv Sourasky Medical CenterTel Aviv