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Trial Outcomes & Findings for Breath Analysis Based Disease Biomarkers (NCT NCT04341012)

NCT ID: NCT04341012

Last Updated: 2026-01-26

Results Overview

Detection of profiles of volatile organic compounds present in exhaled breath. The values in the table represent the number of participants from whom a volatile organic compound profile was able to be detected.

Recruitment status

COMPLETED

Target enrollment

46 participants

Primary outcome timeframe

1 day

Results posted on

2026-01-26

Participant Flow

Participants were enrolled from a specialized liver clinic. There was a need to ensure that sample collection and analysis could be performed within a controlled environment that did not pose risk of exposure or transmission of COVID-19 virus. As this could not be assured at the time, participants were not enrolled for the COVID-19 and other arms.

Participant milestones

Participant milestones
Measure
Healthy Patients
Patients with no known liver disease or cirrhosis
Cirrhosis Patients
Patients with cirrhosis of the liver
Overall Study
STARTED
11
35
Overall Study
COMPLETED
11
35
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Healthy Patients
n=11 Participants
Patients with no known liver disease or cirrhosis
Cirrhosis Patients
n=35 Participants
Patients with cirrhosis of the liver
Total
n=46 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=11 Participants
0 Participants
n=35 Participants
0 Participants
n=46 Participants
Age, Categorical
Between 18 and 65 years
11 Participants
n=11 Participants
32 Participants
n=35 Participants
43 Participants
n=46 Participants
Age, Categorical
>=65 years
0 Participants
n=11 Participants
3 Participants
n=35 Participants
3 Participants
n=46 Participants
Age, Continuous
45 years
n=11 Participants
61 years
n=35 Participants
57 years
n=46 Participants
Sex: Female, Male
Female
6 Participants
n=11 Participants
17 Participants
n=35 Participants
23 Participants
n=46 Participants
Sex: Female, Male
Male
5 Participants
n=11 Participants
18 Participants
n=35 Participants
23 Participants
n=46 Participants
Race and Ethnicity Not Collected
—
—
0 Participants
Race and Ethnicity were not collected from any participant.
Region of Enrollment
United States
11 participants
n=11 Participants
35 participants
n=35 Participants
46 participants
n=46 Participants
Number of subjects enrolled
11 participants
n=11 Participants
35 participants
n=35 Participants
46 participants
n=46 Participants

PRIMARY outcome

Timeframe: 1 day

Detection of profiles of volatile organic compounds present in exhaled breath. The values in the table represent the number of participants from whom a volatile organic compound profile was able to be detected.

Outcome measures

Outcome measures
Measure
Healthy Patients
n=11 Participants
Patients with no known liver disease or cirrhosis
Cirrhosis Patients
n=35 Participants
Patients with cirrhosis of the liver
Breath Volatile Organic Compound Profiles
11 Participants
35 Participants

Adverse Events

Healthy Patients

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Cirrhosis Patients

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Tushar Patel

Mayo Clinic

Phone: 9049532000

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place