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CompletedNCT02685241Updated Oct 18, 2019

Monitoring of Biomarkers by Portable Breath Gas Sensors: an Exploratory Study

An observational study in General Population, sponsored by University of Zurich. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-18.

Sponsored by University of Zurich · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
70
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • General Population

Keywords

  • Exhaled breath
  • Biomarker
03

In context

Lead sponsor

University of Zurich is the lead sponsor of 1,030 studies on the registry; 130 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

General population

Inclusion criteria

  • Informed consent
  • Age ≥ 18 years

Exclusion criteria

Exclusion Criteria:

  • Moribund or severe disease prohibiting protocol adherence
  • Physical or intellectual impairment precluding informed consent or protocol adherence
  • Pregnant patients
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
70 participants (actual)
Patient registry
No

Groups and cohorts

  • General population

    General population

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: one hour, single measurement, no follow-up

Secondary outcomes

  1. 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.

    Time frame: one hour, single measurement, no follow-up

07

Study locations

1 site
  • University Hospital Zurich, Division of Pneumology
    Zurich, ZH 8091, Switzerland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 18, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02685241
Lead sponsor
University of Zurich
Collaborators
Swiss Federal Institute of Technology
Responsible party
Malcolm Kohler (Prof. Dr. med., University of Zurich) — Principal investigator
First posted
Feb 18, 2016
Start date
Jun 2016
Primary completion
Oct 2019
Completion
Oct 2019
Last update
Oct 18, 2019

Study contacts

Malcolm Kohler, MD
principal investigator · University of Zurich

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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