NCT02685241

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 18, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

October 18, 2019

Status Verified

October 1, 2019

Enrollment Period

3.3 years

First QC Date

February 5, 2016

Last Update Submit

October 17, 2019

Conditions

General Population

Keywords

Exhaled breathBiomarker

Outcome Measures

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

    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.

    one hour, single measurement, no follow-up

Study Arms (1)

General population

General population

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

General population

You may qualify if:

  • Informed consent
  • Age ≥ 18 years

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich, Division of Pneumology

Zurich, Canton of Zurich, 8091, Switzerland

Location

Study Officials

  • Malcolm Kohler, MD

    University of Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

February 5, 2016

First Posted

February 18, 2016

Study Start

June 1, 2016

Primary Completion

October 1, 2019

Study Completion

October 1, 2019

Last Updated

October 18, 2019

Record last verified: 2019-10

Locations

CH(1)