NCT04146064Completed
Breathomics as Predictive Biomarker for Checkpoint Inhibitor Response
Breathomics as a Non-invasive, Inexpensive, Point-of-care Predictive Test for Immune Checkpoint Inhibitor Efficacy
Source: ClinicalTrials.gov · Last updated 8 May 2026
Brief summary (registry, in English)
Immunotherapy with agents stimulating the immune system to act against cancer are now a new standard of care in various cancers as lung cancer and melanoma, but also bladder cancer, kidney cancer and head \& neck cancer. However, even though a subset of patients derives long-term benefit from these agents, depending of cancer type still at least half of patients do not respond to these new drugs. Our understanding of possible factors predicting whether a patient might actually benefit from immunotherapy is poor. Volatile organic compounds (VOCs) are gases exhaled with a person's breath, which are released into the lung from blood and bacteria and therefore can give information about infections as well as inflammation and possibly cancer cells in a person's body. Breath analysis of these VOCs with special devices called electronic noses (eNose) generate a specific electric signals patterns called breathprints. There is early evidence that specific breathprints can actually help to select patients who will be likely to benefit from immunotherapy. This study is being undertaken in an effort to evaluate breathprint analysis as a potential predicting factor for benefit from immunotherapy, so that treatment selection can further be improved. This study is designed to help us identify the role of breathprint analysis to better select patients for immunotherapy.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 190 (actual)
- First submitted
- 29 Oct 2019
- Start date
- 24 Feb 2020
- Primary completion date
- 9 Feb 2026
- Lead sponsor
- University Health Network, Toronto
- Diseases
- Head and neck cancer, Kidney cancer, Bladder cancer, Melanoma
- NCT number
- NCT04146064
What you commit to
- Study type: Observational
- Participants enrolled: 190
- From 24 Feb 2020 to the primary completion date, 9 Feb 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- 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.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Princess Margaret Cancer Centre Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.