Volatile Organic Compounds (VOCs) of Exhaled Breath in Patients With GI Bleeding

Analysis of Volatile Organic Compound (VOC) in Exhaled Breath for the Detection of Gastrointestinal Bleeding

Cross sectional case-control study investigating the difference of volatile organic compound in the exhaled breath of the patients with GI bleeding and normal population.

Study Overview

• Status: Unknown
• Conditions: Gastrointestinal Hemorrhage; Volatile Organic Compounds
• Intervention / Treatment: Diagnostic test: Collection of exhaled breath

Detailed Description

This study investigates the difference of volatile organic compound in the exhaled breath of the patients with GI bleeding and normal population. We aimed to find out the biomarkers for GI bleeding.

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: JIN JU CHOI, M.D.; Phone Number: 01028087284; Email: wallet87@hanmail.net

Study Locations

• Korea, Republic of
  • Gyunggi-do
    • Seoul, Gyunggi-do, Korea, Republic of, 02830
      • Recruiting
      • Jin Ju Choi
      • Contact: JIN JU CHOI, M.D.; Phone Number: 01028087284; Email: wallet87@hanmail.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Inclusion Criteria:

• Adults aged 20-80
• Patients who visited emergency room and suspected to have recent or active gastrointestinal bleeding
• Patients who are scheduled to undergo esophagogastroduodenoscopy.

Exclusion Criteria:

• Diagnosis of malignancy diagnosed within 5 years
• Past medical history of chronic liver disease, chronic kidney disease, chronic lung disease, chronic bronchial disease, asthma
• Surgical history of any kind of gastrectomy
• Surgical history of any kind of lung resection which could impact the patient's lung function.

Description

Inclusion Criteria:

• Adults aged between 20 and 80
• Low possibility of gastrointestinal bleeding was proven by esophagogastroduodenoscopy and colonoscopy which were performed within 1 year.
• NSAID non-user (within 1 months before the date of inclusion)

Exclusion Criteria:

• Diagnosis of malignancy diagnosed within 5 years
• Past medical history of chronic liver disease, chronic kidney disease, chronic lung disease, chronic bronchial disease, asthma
• Surgical history of any kind of gastrectomy
• Surgical history of any kind of lung resection which could impact the patient's lung function.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Normal control; Normal population with low prevalence of gastrointestinal bleeding who underwent EGD and CFS which revealed no abnormal finding.	Diagnostic test: Collection of exhaled breath; Collection of exhaled breath will be analyzed for specific volatile organic compounds which show different distribution between groups
Patients with GI bleeding; Patients who visited emergency room and were highly suspected to have recent or active upper GI bleeding and scheduled for upper GI endoscopy.	Diagnostic test: Collection of exhaled breath; Collection of exhaled breath will be analyzed for specific volatile organic compounds which show different distribution between groups

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VOC Patterns	Patterns of volatile organic compounds recognized by sensor array	1 day of 1st emergency room (ER) visit for GI bleeding

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of VOC	Qualitative and quantitative assay of volatile organic compounds by GC-MS	1 day of 1st emergency room (ER) visit for GI bleeding
Change of VOC patterns	Change of the patterns of volatile organic compounds recognized by sensor array after recovery from GI bleeding	2nd visit (about 2weeks apart from 1st visit)

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Study Chair: HYUNSOO CHUNG, M.D., Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2020
• Primary Completion (Anticipated): April 1, 2020
• Study Completion (Anticipated): July 1, 2020

Study Registration Dates

• First Submitted: January 8, 2020
• First Submitted That Met QC Criteria: January 10, 2020
• First Posted (Actual): January 13, 2020

Study Record Updates

• Last Update Posted (Actual): January 13, 2020
• Last Update Submitted That Met QC Criteria: January 10, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Hemorrhage; Gastrointestinal Hemorrhage
• Other Study ID Numbers: 1911-086-107

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No