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COMPLETED
NCT04146064

Breathomics as Predictive Biomarker for Checkpoint Inhibitor Response

Sponsor: University Health Network, Toronto

View on ClinicalTrials.gov

Summary

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.

Official title: Breathomics as a Non-invasive, Inexpensive, Point-of-care Predictive Test for Immune Checkpoint Inhibitor Efficacy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

190

Start Date

2020-02-24

Completion Date

2026-02-09

Last Updated

2026-05-08

Healthy Volunteers

No

Interventions

OTHER

Breathprint analysis and patient-reported outcomes

Breathprint analysis: Patients will be providing breathprint samples into the eNose device at baseline and every 12 weeks thereafter as long as on immunotherapy treatment. Questionnaires will be completed at the same timepoints.

Locations (1)

Princess Margaret Cancer Centre

Toronto, Ontario, Canada