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Breath test could spot breast cancer without needles or scans

NCT ID NCT06499077

Diagnosis Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing whether a simple breath test can tell if a woman has breast cancer. Researchers are collecting breath samples from 1000 women — half with breast cancer and half without — and analyzing them with a mass spectrometer. The goal is to see if the chemical signature in the breath of cancer patients is different from healthy controls. If it works, it could lead to a painless, non-invasive way to screen for breast cancer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to a simple, non-invasive breath test to help detect breast cancer early.
What could go wrong
This is an early observational study, not a treatment trial. The breath test may not be accurate enough to replace standard screening methods.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

1,000 people

The number who actually took part.

Started

Jun 2021

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 to 98 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 \-

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Conditions

The condition(s) this trial relates to.

breast neoplasm invasive breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast neoplasm female

Contacts and locations

Locations

  • Fondazione IRCCS Istituto Nazionale Tumori

    Milan, Italy

More trials for these conditions

Other studies related to the condition(s) this trial covers.