Non-invasive Detection of Breast Cancer by Breath Analysis

Active, not recruiting

• Conditions: Breast Neoplasm Female
• Interventions: Diagnostic Test: Sampling of exhaled breath

• Registration Number: NCT06499077
• Lead Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Brief Summary

The goal of this prospective observational study is to compare the exhaled breath profiles of patient with invasive breast cancer and control subjects in the perspective of a diagnostic application in oncology.

The main question it aims to answer is whether the exhaled breath profile of breast cancer patients can be discriminate from the exhaled breath of control subjects.

Participants to the study are recruited in a first discovery series including about 500 subjects and in a following independent validation series including more than 400 subjects. Breath samples are collected in a dedicated room using sampling bags and following anti-Covid-19 measures. Only authorized personnel could access the sampling room which was equipped with a HEPA Filter air purification system. Sampling bags are made of Nalophan® tubular foil and 2 taps, one in which the study participant inflated with their breath and sealed after use, while the second is used to introduce breath samples into the analyzer. Bags are sterilized with the Sterrad™ system with H2O2 vapors before use. To contain the potentially infectious particulate included in the participant exhaled breath, an electrostatic filter is mounted on the tap of the bag used to inflate it with breath. All participants are supplied with a leaflet explaining aims and technical/clinical information of the study. At each breath sampling, study participants are asked not to smoke, eat, drink (except for water), brush their teeth or use lipstick for at least 2 h before breath collection to minimize the presence of contaminant molecules in exhaled breath.

Breath profiling is performed by mass spectrometry analysis using an untargeted approach. Breath samples are profiled by Secondary Electrospray ionization - High resolution Mass Spectrometry (SESI-HR-MS) using a high resolution instrumentation (LTQ Orbitrap Elite,Thermo Fisher Scientific) equipped with a SuperSESI ionization source (Fossiliontech).

Data analysis is based on our previous work (Martínez-Lozano el al., 2015 J Breath Res 9:031001) and will be implemented with machine learning and other Artificial Intelligence (AI) methods.

Once all the breath profiles will be collected and analysed, researchers will compare data from patient with breast cancer and data from tumor-free subjects to identify methods and patterns able to specifically identify the pathological breath samples and discriminate them from the control breath samples.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-03
• Primary Completion: 2024-03-29
• Status Verified: 2024-05
• Study First Submitted: 2024-06-04
• Study First Submitted QC: 2024-07-08
• Last Update Submitted: 2024-07-08
• Study First Posted: 2024-07-12
• Last Update Posted: 2024-07-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 1000

Inclusion Criteria

1. be >= 18 years
2. Patients

2.a patients at early stage of breast cancer 2.b exahled breath collected and analysed at the baseline before any surgical or pharmacological treatment

3. Controls 3.1 subjects with negative breast imaging (BI-RADS= 1,2) 3.2 exhaled breath collected and analysed on the day of breast screening

Exclusion Criteria

1. any cancer in the 5 years before the inclusion

2. major surgery within 4 weeks before the inclusion

3. previous or concomitant long-term treatment with systemic steroids or immunosuppressive/immunomodulating drugs

4. concomitant acute infection, viral hepatitis, HIV infection, COVID19 infection or other serious concomitant medical disorders

5. organ allograft

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Tumor	Sampling of exhaled breath	Women carrying a breast cancer
Control	Sampling of exhaled breath	Women with negative breast imaging

Primary Outcome Measures

Name	Time	Method
Classification of the exhaled breath of breast cancer patients and controls as assessed by the comparison of the global breath profile of volatile organic compounds (VOCs) measured using Mass Spectrometry analysis.	Breath collection and MS analysis were assessed at the baseline.	Breath profile of each study participant was determined by Mass Spectrometry analysis (Secondary Electrospray ionization - High resolution Mass Spectrometry, SESI-HR-MS). The risk of cancer is identified in the validation cohort of the present study and is based on the diagnostic model developed in the discovery phase of the same study. The predictive result is compared, in the case of breast cancer patients, with the histopathological proven diagnosis and, in the case of control subjects, with the imaging proven diagnosis.

Trial Locations

Locations (1)

Fondazione IRCCS Istituto Nazionale Tumori; 🇮🇹 Milan, Italy