Volatile Organic CompoundVOCsAUGIBNCT06877507
Rapid Diagnostic Technology for AUGIB Based on Analysis of VOCs in Exhaled Breath
An observational study of Volatile Organic Compound and Gastrointestinal Hemorrhage, run by Beijing 302 Hospital.
Trial summary
This study aims to develop a non-invasive and rapid diagnostic technology for acute upper gastrointestinal bleeding (AUGIB) by analyzing volatile organic compounds (VOCs) in exhaled breath. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Volatile Organic Compound, Gastrointestinal Hemorrhage
- What is being tested?
- Gastroscopy and Gas Chromatography - Mass Spectrometry
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 20 Mar 2025to 20 Jul 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients requiring endoscopy for suspected AUGIB
Who may be able to join
- Age ≥18 years;
- Clinical suspicion of AUGIB (e.g., hematemesis, melena);
- Fasting ≥4 hours;
- Signed informed consent.
Who cannot join
- Severe pulmonary dysfunction or recent lung infection (within 1 week);
- Cardiac/renal failure or disseminated intravascular coagulation;
- Contraindications to endoscopy;
- High-risk conditions (e.g., massive ascites);
- Alcohol consumption within 24 hours;
- Pregnancy.
About this study
Official title: Rapid Diagnostic Technology for Acute Upper Gastrointestinal Bleeding Based on Analysis of Volatile Organic Compounds (VOCs) in Exhaled Breath
This study aims to develop a non-invasive and rapid diagnostic technology for acute upper gastrointestinal bleeding (AUGIB) by analyzing volatile organic compounds (VOCs) in exhaled breath. Clinically confirmed patients will be divided into three groups (no bleeding, minor bleeding, major bleeding) based on endoscopic findings. VOC profiles will be analyzed to construct a predictive model, validated for sensitivity and specificity (both targets ≥0.7). This approach addresses the limitations of endoscopy in emergency or resource-limited settings, improving diagnostic efficiency and reducing mortality.
Read the detailed description
Acute upper gastrointestinal bleeding (AUGIB) is a common emergency with an annual incidence of 100-180/100,000 and mortality of 2%-15%. Endoscopy, the gold standard, is invasive and equipment-dependent, limiting its use in primary care or emergencies. Exhaled breath VOCs analysis, a non-invasive and portable method, has been applied in other diseases but not yet explored for AUGIB.
Objectives:
- Identify characteristic VOC profiles in exhaled breath of AUGIB patients.
- Develop a VOC-based predictive model with sensitivity and specificity ≥0.7.
- Establish rapid diagnostic criteria to enhance clinical decision-making.
- Being tested
- Gastroscopy, Gas Chromatography - Mass Spectrometry
- Keywords
- Volatile Organic Compound, Acute Upper Gastrointestinal Bleeding, Exhaled Breath
- Medical subject headings
- Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GastroscopyDevice
Gastroscopy for all included patients
Gas Chromatography - Mass SpectrometryDiagnostic test
Using a patient's exhaled breath test with Gas Chromatography - Mass Spectrometry
| Study group | Role | What they receive |
|---|---|---|
| No bleeding | No blood in the upper gastrointestinal tract Receives: Device: Gastroscopy; Diagnostic Test: Gas Chromatography - Mass Spectrometry | |
| Minor bleeding | A little blood in the upper gastrointestinal tract Receives: Device: Gastroscopy; Diagnostic Test: Gas Chromatography - Mass Spectrometry | |
| Major bleeding | Plenty of blood in the upper gastrointestinal tract Receives: Device: Gastroscopy; Diagnostic Test: Gas Chromatography - Mass Spectrometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of the diagnostic model
targets ≥0.7
Measured: 4 months
Secondary outcomes (2)
Identification of key VOCs
e.g., aldehydes, ketones
Measured: 4 months
Differences in VOC concentrations across 3 bleeding severity groups
Different VOCs
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start20 Mar 2025 (estimated)
- Primary completion20 Jul 2025 (estimated)
- Study completion20 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Volatile Organic CompoundStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing 302 Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06877507
- Sponsor's protocol ID
- 302-2025-VOCs
- Other IDs
- 82270694
- Acronym
- VOCsAUGIB
- Status last verified
- Mar 2025
- First submitted
- 10 Mar 2025
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Diagnostic Technology for Acute Upper Gastrointestinal Bleeding Based on Analysis of Volatile Organic Compounds (VOCs) in Exhaled Breath
- ClinicalTrials.gov ID
- NCT06877507
- Acronym / sponsor ID
- VOCsAUGIB / 302-2025-VOCs
- Keywords
- Volatile Organic Compound, Acute Upper Gastrointestinal Bleeding, Exhaled Breath
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Beijing 302 HospitalUniversity, hospital or other
- Study start
- 20 Mar 2025 (estimated)
- Primary completion
- 20 Jul 2025 (estimated)
- Study completion
- 20 Jul 2025 (estimated)
- First posted
- 14 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to develop a non-invasive and rapid diagnostic technology for acute upper gastrointestinal bleeding (AUGIB) by analyzing volatile organic compounds (VOCs) in exhaled breath. Clinically confirmed patients will be divided into three groups (no bleeding, minor bleeding, major bleeding) based on endoscopic findings. VOC profiles will be analyzed to construct a predictive model, validated for sensitivity and specificity (both targets ≥0.7). This approach addresses the limitations of endoscopy in emergency or resource-limited settings, improving diagnostic efficiency and reducing mortality.
Detailed description
Acute upper gastrointestinal bleeding (AUGIB) is a common emergency with an annual incidence of 100-180/100,000 and mortality of 2%-15%. Endoscopy, the gold standard, is invasive and equipment-dependent, limiting its use in primary care or emergencies. Exhaled breath VOCs analysis, a non-invasive and portable method, has been applied in other diseases but not yet explored for AUGIB.
Objectives:
- Identify characteristic VOC profiles in exhaled breath of AUGIB patients.
- Develop a VOC-based predictive model with sensitivity and specificity ≥0.7.
- Establish rapid diagnostic criteria to enhance clinical decision-making.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No bleeding | – | Device: Gastroscopy, Diagnostic Test: Gas Chromatography - Mass SpectrometryNo blood in the upper gastrointestinal tract |
| Minor bleeding | – | Device: Gastroscopy, Diagnostic Test: Gas Chromatography - Mass SpectrometryA little blood in the upper gastrointestinal tract |
| Major bleeding | – | Device: Gastroscopy, Diagnostic Test: Gas Chromatography - Mass SpectrometryPlenty of blood in the upper gastrointestinal tract |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients requiring endoscopy for suspected AUGIB
Key inclusion criteria (4 listed)
- Age ≥18 years;
- Clinical suspicion of AUGIB (e.g., hematemesis, melena);
- Fasting ≥4 hours;
- Signed informed consent.
Key exclusion criteria (6 listed)
- Severe pulmonary dysfunction or recent lung infection (within 1 week);
- Cardiac/renal failure or disseminated intravascular coagulation;
- Contraindications to endoscopy;
- High-risk conditions (e.g., massive ascites);
- Alcohol consumption within 24 hours;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GastroscopyGastroscopy for all included patients | Device | Major bleeding, Minor bleeding, No bleeding |
| Gas Chromatography - Mass SpectrometryUsing a patient's exhaled breath test with Gas Chromatography - Mass Spectrometry | Diagnostic test | Major bleeding, Minor bleeding, No bleeding |
Primary outcome
Sensitivity and specificity of the diagnostic model
Time frame: 4 months
targets ≥0.7
2 secondary outcomes
Identification of key VOCs
Time frame: 4 months
Differences in VOC concentrations across 3 bleeding severity groups
Time frame: 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Volatile Organic Compound and Gastrointestinal Hemorrhage, run by Beijing 302 Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of the diagnostic model (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025; AzTrials last refreshed its copy on 7 Nov 2026.