Breath analysis to predict response to cancer immunotherapy
Breathomics as a Non-invasive, Inexpensive, Point-of-care Predictive Test for Immune Checkpoint Inhibitor Efficacy
This study is testing if analyzing breath patterns can help doctors predict how well cancer patients will respond to immunotherapy treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 425 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Health Network, Toronto Academic / other |
| Drugs / interventions | Pembrolizumab, Nivolumab, ipilimumab, chemotherapy, Immunotherapy |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT04146064 on ClinicalTrials.gov |
What this trial studies
This observational study aims to validate the effectiveness of breathprint analysis using electronic noses (eNoses) as a predictive biomarker for patient response to immunotherapy in various cancers, including non-small cell lung cancer (NSCLC), melanoma, kidney cancer, and others. By analyzing volatile organic compounds (VOCs) in patients' breath, the study seeks to identify specific breath patterns that correlate with treatment outcomes. The goal is to improve patient selection for immunotherapy, potentially reducing unnecessary side effects and costs associated with ineffective treatments.
Who should consider this trial
Good fit: Ideal candidates include adults with advanced or metastatic NSCLC, melanoma, or other specified solid tumors who are scheduled to receive immunotherapy.
Not a fit: Patients who are unable to perform the necessary breathing maneuvers for breath analysis will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more personalized and effective treatment plans for cancer patients, enhancing their chances of benefiting from immunotherapy.
How similar studies have performed: Preliminary studies have shown promising results in using breathprint analysis for predicting immunotherapy responses, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Toronto, Ontario
- Princess Margaret Cancer Centre — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Geoffrey Liu, MD MSc — Uhn
- Study coordinator: Sabine Schmid, MD
- Email: sabine.schmid@uhn.ca
- Phone: 416-946-2000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.