Non-invasive Detection of Breast Cancer by Breath Analysis

NCT ID: NCT06499077

Last Updated: 2024-07-12

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-06-03
• Study Completion Date: 2025-12-31

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.

Conditions

Breast Neoplasm Female

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Tumor

Women carrying a breast cancer

Sampling of exhaled breath

Intervention Type: DIAGNOSTIC_TEST

Exhaled breath of all participants is collected following our standardized procedure

Control

Women with negative breast imaging

Sampling of exhaled breath

Intervention Type: DIAGNOSTIC_TEST

Exhaled breath of all participants is collected following our standardized procedure

Interventions

Sampling of exhaled breath

Exhaled breath of all participants is collected following our standardized procedure

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

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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

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• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 98 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rosaria Orlandi

Role: PRINCIPAL_INVESTIGATOR

Fondazione IRCCS ISTITUTO NAZIONALE TUMORI

Locations

Fondazione IRCCS Istituto Nazionale Tumori

Milan, , Italy

Countries

Italy

References

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.

Reference Type: BACKGROUND

PMID: 26390050 (View on PubMed)

Other Identifiers

IstitutoTumori-BreathBC

Identifier Type: -

Identifier Source: org_study_id