NCT07038785 Identification of Breast Cancer in Breath Samples Using Trained Detection Dogs
| NCT ID | NCT07038785 |
| Status | Recruiting |
| Phase | — |
| Sponsor | SpotitEarly |
| Condition | Breast Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,204 participants |
| Start Date | 2025-07-22 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,204 participants in total. It began in 2025-07-22 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07038785 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07038785 currently recruiting?
Yes, NCT07038785 is actively recruiting participants. Contact the research team at udi@spotitearly.com for enrollment information.
Where is the NCT07038785 trial being conducted?
This trial is being conducted at Totowa, United States, Philadelphia, United States, Haifa, Israel, Ramat Gan, Israel and 2 additional locations.
Who is sponsoring the NCT07038785 clinical trial?
NCT07038785 is sponsored by SpotitEarly. The trial plans to enroll 1,204 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.