Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in the USA / NCT07038785
Recruiting Observational

Identification of Breast Cancer in Breath Samples Using Trained Detection Dogs

NCT07038785 · tracked via the Priya Life Science USA tracker
Sponsor
SpotitEarly
Phase
Observational
Started
2025-07-22
Last updated
2026-05-15

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

Breath test

Breath test: Breath sample collection using a sample collection kit

Study 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

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • 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.

Trial sites (6)

FacilityCityRegionStatus
Hackensack Meridian Health Totowa New Jersey Recruiting
Hospital of the University of Pennsylvania Philadelphia Pennsylvania Recruiting
Rambam Health Care Campus Haifa Israel Recruiting
Sheba Medical Center Ramat Gan Israel Recruiting
Assuta Medical Centers Tel Aviv Israel Recruiting
Tel Aviv Sourasky Medical Center Tel Aviv Israel Recruiting

Other trials for the same condition

Study of LEE011, BYL719 and Letrozole in Advanced ER+ Breast Cancer Active, not recruiting
Evaluation of Improved Onboard Patient Imaging Active, not recruiting
Dose Escalation and Dose Expansion Study of MDX2001 in Patients With Advanced Solid Tumors Recruiting
A Study of Dato-DXd in Inoperable or Metastatic Hormone Receptor-positive, HER2 IHC 0 Breast Cancer Recruiting
Study of the Bria-IMT Regimen and CPI vs Physicians' Choice in Advanced Metastatic Breast Cancer. Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07038785 on ClinicalTrials.gov ↗ ← All trials in the USA