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Not yet recruitingNCT06877507VOCsAUGIBUpdated Mar 14, 2025

Rapid Diagnostic Technology for AUGIB Based on Analysis of VOCs in Exhaled Breath

An observational study in Volatile Organic Compound and Gastrointestinal Hemorrhage, sponsored by Beijing 302 Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-14.

Sponsored by Beijing 302 Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Jul 2025, 1 year 2 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
All
01

Study 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. 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:

  1. Identify characteristic VOC profiles in exhaled breath of AUGIB patients.
  2. Develop a VOC-based predictive model with sensitivity and specificity ≥0.7.
  3. Establish rapid diagnostic criteria to enhance clinical decision-making.
02

Conditions studied

  • Volatile Organic Compound
  • Gastrointestinal Hemorrhage

Keywords

  • Volatile Organic Compound
  • Acute Upper Gastrointestinal Bleeding
  • Exhaled Breath
03

In context

Gastrointestinal Hemorrhage

339 studies on the registry are indexed under Gastrointestinal Hemorrhage; 79 are open to participants now.

This study's planned enrollment of 200 is close to the median of 200 across 116 observational studies indexed under Gastrointestinal Hemorrhage.

Browse Gastrointestinal Hemorrhage studies →

Lead sponsor

Beijing 302 Hospital is the lead sponsor of 86 studies on the registry; 31 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
No
Sampling method
Probability sample

Study population

Patients requiring endoscopy for suspected AUGIB

Inclusion criteria

  1. Age ≥18 years;
  2. Clinical suspicion of AUGIB (e.g., hematemesis, melena);
  3. Fasting ≥4 hours;
  4. Signed informed consent.

Exclusion criteria

Exclusion Criteria:

  1. Severe pulmonary dysfunction or recent lung infection (within 1 week);
  2. Cardiac/renal failure or disseminated intravascular coagulation;
  3. Contraindications to endoscopy;
  4. High-risk conditions (e.g., massive ascites);
  5. Alcohol consumption within 24 hours;
  6. Pregnancy.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • No bleeding

    No blood in the upper gastrointestinal tract

    Device: Gastroscopy · Diagnostic Test: Gas Chromatography - Mass Spectrometry

  • Minor bleeding

    A little blood in the upper gastrointestinal tract

    Device: Gastroscopy · Diagnostic Test: Gas Chromatography - Mass Spectrometry

  • Major bleeding

    Plenty of blood in the upper gastrointestinal tract

    Device: Gastroscopy · Diagnostic Test: Gas Chromatography - Mass Spectrometry

Interventions

  • DeviceGastroscopy

    Gastroscopy for all included patients

  • Diagnostic testGas Chromatography - Mass Spectrometry

    Using a patient's exhaled breath test with Gas Chromatography - Mass Spectrometry

06

What researchers measure

Primary outcomes

  1. Sensitivity and specificity of the diagnostic model

    targets ≥0.7

    Time frame: 4 months

Secondary outcomes

  1. Identification of key VOCs

    e.g., aldehydes, ketones

    Time frame: 4 months

  2. Differences in VOC concentrations across 3 bleeding severity groups

    Different VOCs

    Time frame: 4 months

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06877507
Lead sponsor
Beijing 302 Hospital
Responsible party
Sponsor
First posted
Mar 14, 2025
Start date
Mar 20, 2025 (estimated)
Primary completion
Jul 20, 2025 (estimated)
Completion
Jul 20, 2025 (estimated)
Last update
Mar 14, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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