Breast Neoplasm FemaleBreathBCNCT06499077
Non-invasive Detection of Breast Cancer by Breath Analysis
An observational study of Breast Neoplasm Female, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 98 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Neoplasm Female
- What is being tested?
- Sampling of exhaled breath
- How many people
- 1,000 participants
- Where
- 1 siteItaly
- Study dates
- 3 Jun 2021to 31 Dec 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 98 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients are recruited at Breast Surgery unit of Fondazione IRCCS Istituto Nazionale Tumori in Milan. Controls are recruited during breast screening at Breast Imaging Unit of Fondazione IRCCS Istituto Nazionale Tumori in Milan.
Who may be able to join
- be >= 18 years
- 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
- -
Who cannot join
- any cancer in the 5 years before the inclusion
- major surgery within 4 weeks before the inclusion
- previous or concomitant long-term treatment with systemic steroids or immunosuppressive/immunomodulating drugs
- concomitant acute infection, viral hepatitis, HIV infection, COVID19 infection or other serious concomitant medical disorders
- organ allograft
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-invasive Detection of Breast Cancer by Mass-spectrometry-based Profiling of Exhaled Breath
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.
Read more
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.
- Conditions
- Breast Neoplasm Female
- Being tested
- Sampling of exhaled breath
- Keywords
- breath analysis, non invasive detection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sampling of exhaled breathDiagnostic test
Exhaled breath of all participants is collected following our standardized procedure
| Study group | Role | What they receive |
|---|---|---|
| Tumor | Women carrying a breast cancer Receives: Diagnostic Test: Sampling of exhaled breath | |
| Control | Women with negative breast imaging Receives: Diagnostic Test: Sampling of exhaled breath |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 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.
Measured: Breath collection and MS analysis were assessed at the baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start3 Jun 2021
- Primary completion29 Mar 2024
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Neoplasm FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rosaria Orlandi, Principal investigator, Fondazione IRCCS ISTITUTO NAZIONALE TUMORI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06499077
- Sponsor's protocol ID
- IstitutoTumori-BreathBC
- Acronym
- BreathBC
- Status last verified
- Dec 2025
- First submitted
- 4 Jun 2024
- Last updated
- 15 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Martinez-Lozano Sinues P, Landoni E, Miceli R, Dibari VF, Dugo M, Agresti R, Tagliabue E, Cristoni S, Orlandi R. Secondary electrospray ionization-mass spectrometry and a novel statistical bioinformatic approach identifies a cancer-related profile in exhaled breath of breast cancer patients: a pilot study. J Breath Res. 2015 Sep 21;9(3):031001. doi: 10.1088/1752-7155/9/3/031001.
PubMed 26390050