Breast Cancer
Conditions
Keywords
Breast Cancer, Screening, Breath Samples, Cancer Detection
Brief 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.
Interventions
DIAGNOSTIC_TESTBreath test
Breath sample collection using a sample collection kit
Sponsors
SpotitEarly
Hackensack Meridian Health
University of Pennsylvania
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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 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. 6. Scheduled for routine annual breast cancer screening (Mammogram, Ultrasound and MRI) INCLUSION CRITERIA FOR ARM 2 (ENRICHED ARM) 1. Capable of giving informed consent for self, which includes compliance with the requirements and restrictions listed in the 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, PTEN , PALB2 OR 5. 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. 6. BI-RADS® score of 4B. 7. Scheduled for breast biopsy.
Exclusion criteria
(BOTH STUDY ARMS) 1. Had cancer within the past year. Individuals who underwent surgical removal of cancerous non-metastatic skin lesions can be recruited. 2. Has received any cancer treatments within the past year. 3. Has participated in another clinical study in the past 30 days. 4. Had bilateral mastectomy for breast cancer or for preventive reasons related to breast cancer. 5. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Test Performance Evaluation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Test Performance Evaluation in different subgroups | 24 months | Sensitivity and specificity of the SpotitEarly test will be measured and compared in each of the subgroups: * Age: under 40, 40-49, 50-64, 65 and older. * Race: White, Black/African American, Asian. * Ethnicity: hispanic vs. non hispanic * Germline pathogenic variant carriers associated with high risk for breast cancer versus non carriers. * Smoking status: smokers versus nonsmokers. * Women with type-2 diabetes versus not diagnosed with type-2 diabetes Sensitivity is the number of participants with a true positive result divided by the number of participants with a positive clinical diagnosis (positive biopsy). Specificity is the number of participants with a true negative result divided by the number of participants with a negative clinical diagnosis. |
| Test Performance in early-stage cancer | 24 months | To evaluate the performance (sensitivity and specificity) of the SpotitEarly test in detecting early-stage breast cancer (stages 0-2). Sensitivity is the number of participants with a true positive result divided by the number of participants with a positive clinical diagnosis (positive biopsy). Specificity is the number of participants with a true negative result divided by the number of participants with a negative clinical diagnosis. |
| Test Performance in the clinic vs. at patients' home | 24 months | To evaluate the performance (sensitivity and specificity, as described in 3.4) of the SpotitEarly test over samples provided by participants at their home. Sensitivity is the number of participants with a true positive result divided by the number of participants with a positive clinical diagnosis (positive biopsy). Specificity is the number of participants with a true negative result divided by the number of participants with a negative clinical diagnosis. |
| Effect of psychological impacts on performance in the enriched arm | 12 months | To assess whether the performance (sensitivity and specificity) of the SpotitEarly test is affected by the subject's psychological impacts (anxiety is assumed for all arm 2 subjects who are undergoing a biopsy). Sensitivity is the number of participants with a true positive result divided by the number of participants with a positive clinical diagnosis (positive biopsy). Specificity is the number of participants with a true negative result divided by the number of participants with a negative clinical diagnosis. |
Countries
Israel, United States
Contacts
CONTACTUdi Bobrovsky
Outcome results
None listed