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Breath sniffing device may predict cancer drug success

NCT ID NCT04146064

Diagnosis Sponsor: University Health Network, Toronto 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a simple breath test can predict if cancer patients will respond to immunotherapy drugs. Researchers used an electronic nose device to analyze breath samples from 190 patients with lung, melanoma, kidney, bladder, or head and neck cancers. The goal is to develop a non-invasive, inexpensive way to select the right treatment for each patient.

What this could mean

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

Active substance
breathprint analysis using an electronic nose device
What this could lead to
If successful, this breath test could help doctors quickly and cheaply identify which patients are likely to benefit from immunotherapy, avoiding ineffective treatments.
What could go wrong
This is an early-stage, observational study. The breath test may not prove accurate enough for routine use, and results may not apply to all cancer types or treatments.

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

190 people

The number who actually took part.

Started

Feb 2020

Finished

Feb 2026

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

Subjects included in this study are patients over the age of 18 years with a histologically-confirmed diagnosis of non-small cell lung cancer, melanoma or other solid tumor for which ICI-treatment is a standard of care. Patients must have advanced/metastatic disease and planning to receive ICI treatment (categories defined above) or chemotherapy treatment (cohort 4) at the Princess Margaret Cancer Centre/University Health Network. Study subjects will be consented specifically for that study.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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 * Patients 18 years of age or older * Histologically confirmed advanced/metastatic non-small cell lung cancer, melanoma or solid tumor such as urothelial, kidney or head and neck cancer and planned treatment with * NSCLC validation cohort: Pembrolizumab or Nivolumab * NSCLC Cohort 1: Pembrolizumab-chemotherapy combination therapy 1L * Melanoma Cohort 2: Nivolumab/ipilimumab combination treatment 1L, Pembrolizumab or nivolumab monotherapy treatment 1L , Ipilimumab * Solid tumors Cohort 3: Any ICI-treatment, any line * NSCLC Cohort 4: Chemotherapy-only (either platinum-based combination treatment or docetaxel monotherapy) * At least one measurable lesion as defined by RECIST 1.1. A lesion at a previously irradiated site may only be counted as a target lesion if there is clear sign of progression since the irradiation. * Able to provide informed consent. EXCLUSION CRITERIA * Patients who are unable to perform the breathing manoeuvres needed for eNose-analysis of exhaled air. * Patients who are unable to independently consent to participation in the trial. * Patients with severe, acute, or chronic medical conditions (including uncontrolled diabetes mellitus) or psychiatric conditions or laboratory abnormalities that in the opinion of the Investigator or their physician may cause undue harm or inconvenience to the patient, or that may interfere with the interpretation of study results.

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Conditions

The condition(s) this trial relates to.

head and neck cancer Head and Neck Neoplasms kidney cancer melanoma non-small cell lung carcinoma transitional cell carcinoma urothelial carcinoma

As listed by the trial registrant

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

Head and neck cancer Kidney cancer Melanoma NSCLC Urothelial carcinoma

Contacts and locations

Locations

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9, Canada

More trials for these conditions

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