Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the study is to develop a clinical test based on breath analysis that can be used for disease diagnosis or prognosis.
The study will seek to collect and analyze breath samples from a broad range of patients to develop reference ranges and to refine the testing methods. Protocols for breath sample collection and algorithms for analysis will be developed. Samples will be collected from normal volunteers, persons with documented liver disease, organ transplant or with known COVID-19 test results.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal | No known medical conditions |
| |
| Liver Cirrhosis | Clinically diagnosed with cirrhosis |
| |
| COVID-19 tested | Persons with known test results for COVID-19 RNA |
| |
| Other | Persons with other medical diagnosis, no known liver disease, negative for COVID-19 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Collection of breath sample | Diagnostic Test | Analysis of volatile organic compounds in breath |
|
| Measure | Description | Time Frame |
|---|---|---|
| Breath Volatile Organic Compound Profiles | 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. | 1 day |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Subjects who are undergoing evaluation and obtaining clinical care at Mayo Clinic in Florida will be enrolled
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Tushar Patel | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Florida | Jacksonville | Florida | 32224 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34847181 | Result | Thomas JN, Roopkumar J, Patel T. Machine learning analysis of volatolomic profiles in breath can identify non-invasive biomarkers of liver disease: A pilot study. PLoS One. 2021 Nov 30;16(11):e0260098. doi: 10.1371/journal.pone.0260098. eCollection 2021. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Patients | Patients with no known liver disease or cirrhosis |
| FG001 | Cirrhosis Patients | Patients with cirrhosis of the liver |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
sequentially enrolled patients
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Patients | Patients with no known liver disease or cirrhosis |
| BG001 | Cirrhosis Patients | Patients with cirrhosis of the liver |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Breath Volatile Organic Compound Profiles | 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. | Posted | Count of Participants | Participants | No | 1 day |
|
1 day
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Healthy Patients | Patients with no known liver disease or cirrhosis | 0 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tushar Patel | Mayo Clinic | 9049532000 | patel.tushar@mayo.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 18, 2020 | Nov 4, 2024 | Prot_000.pdf |
Not provided
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D008113 | Liver Neoplasms |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Number of subjects enrolled | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Cirrhosis Patients | Patients with cirrhosis of the liver | 0 | 35 | 0 | 35 | 0 | 35 |
Not provided
Not provided
Not provided
| D011024 |
| Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |