Clinical trial NCT02685241: Monitoring of Biomarkers by Portable Breath Gas Sensors: an Exploratory Study
Official title: Monitoring of Biomarkers by Portable Breath Gas Sensors: an Exploratory Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: General Population
Keywords: Exhaled breath
Biomarker
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Swiss Federal Institute of Technology
First posted: 2016-02-18
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: General population

Brief summary: Breath analysis is a non-invasive procedure to detect and monitor diseases and it is particularly attractive for patients who have to routinely check biomarkers, such as diabetics (blood glucose) or end-stage renal disease patients (creatinine). Preliminary data in a small study with healthy subjects showed a high correlation between blood glucose levels and acetone. Therefore, the objective of this study is to correlate biomarkers (glucose level and creatinine, respectively) with the corresponding target breath components (acetone and NH3, respectively) detected by portable gas sensors in the general population and to assess possible predictive models for biomarker estimations from the corresponding target breath component and predictive models to estimate abnormal biomarker concentrations.

Detailed description: Breath analysis is a non-invasive procedure to detect and monitor diseases and it is particularly attractive for patients who have to routinely check biomarkers, such as diabetics (blood glucose) or end-stage renal disease patients (creatinine). The proposed breath sensors analyse breath in real-time with on-line display of breath parameters, are portable, simple to operate, inexpensive and offer a sufficiently low limit of detection for the target breath markers, thus making them of high interest for daily clinical practice. Preliminary data in a small study with healthy subjects showed a high correlation between blood glucose levels and acetone.

The primary objective of this study is to correlate biomarkers (glucose level and creatinine, respectively) with the corresponding target breath components (acetone and NH3, respectively) detected by portable gas sensors in the general population. The secondary objectives of the study are to assess possible predictive models for biomarker estimations from the corresponding target breath component and predictive models to estimate abnormal biomarker concentrations.

Eligibility criteria: Inclusion Criteria:

* Informed consent
* Age ≥ 18 years

Exclusion Criteria:

* Moribund or severe disease prohibiting protocol adherence
* Physical or intellectual impairment precluding informed consent or protocol adherence
* Pregnant patients

Primary outcomes:
measure: The primary outcome will be the correlation between biomarkers (glucose levels and creatinine, respectively) and target breath components (acetone and NH3, respectively) detected by portable gas sensors
timeFrame: one hour, single measurement, no follow-up
Secondary outcomes:
measure: The assessment of possible predictive models for biomarker estimations (glucose levels and creatinine) from the corresponding target breath component (acetone and NH3) and predictive models to estimate the abnormal biomarker concentrations.
timeFrame: one hour, single measurement, no follow-up
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Division of Pneumology
state: ZH
Study officials:
affiliation: University of Zurich
name: Malcolm Kohler, MD
role: PRINCIPAL_INVESTIGATOR
References: