Gastrointestinal HemorrhageNCT04226079
Volatile Organic Compounds (VOCs) of Exhaled Breath in Patients With GI Bleeding
An observational study of Gastrointestinal Hemorrhage and Volatile Organic Compounds, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Hemorrhage, Volatile Organic Compounds
- What is being tested?
- Collection of exhaled breath
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2020to Jul 2020
- How long will I take part?
- 2 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Jin Ju Choi
Seoul, Gyunggi-do, 02830
JIN JU CHOI, M.D., 01028087284, wallet87@hanmail.net
About this study
Official title: 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.
Read the 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.
- Being tested
- Collection of 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.
Collection of exhaled breathDiagnostic test
Collection of exhaled breath will be analyzed for specific volatile organic compounds which show different distribution between groups
| Study group | Role | What they receive |
|---|---|---|
| Normal control | Normal population with low prevalence of gastrointestinal bleeding who underwent EGD and CFS which revealed no abnormal finding. Receives: Diagnostic Test: Collection of exhaled breath | |
| 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. Receives: Diagnostic Test: Collection of exhaled breath |
What is being measured
The primary outcome is the main question the study is designed to answer.
VOC Patterns
Patterns of volatile organic compounds recognized by sensor array
Measured: 1 day of 1st emergency room (ER) visit for GI bleeding
Secondary outcomes (2)
Measurement of VOC
Qualitative and quantitative assay of volatile organic compounds by GC-MS
Measured: 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
Measured: 2nd visit (about 2weeks apart from 1st visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study startJan 2020 (estimated)
- Primary completionApr 2020 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal HemorrhageStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- 60 participants (estimated)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyunsoo Chung, Seoul National University Hospital
- Investigators
- HYUNSOO CHUNG, M.D., Study chair, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04226079
- Sponsor's protocol ID
- 1911-086-107
- Status last verified
- Jan 2020
- First submitted
- 8 Jan 2020
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Volatile Organic Compound (VOC) in Exhaled Breath for the Detection of Gastrointestinal Bleeding
- ClinicalTrials.gov ID
- NCT04226079
- Acronym / sponsor ID
- 1911-086-107
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jan 2020 (estimated)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 13 Jan 2020 (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.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal control | – | Diagnostic Test: Collection of exhaled breathNormal population with low prevalence of gastrointestinal bleeding who underwent EGD and CFS which revealed no abnormal finding. |
| Patients with GI bleeding | – | Diagnostic Test: Collection of exhaled breathPatients who visited emergency room and were highly suspected to have recent or active upper GI bleeding and scheduled for upper GI endoscopy. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Collection of exhaled breathCollection of exhaled breath will be analyzed for specific volatile organic compounds which show different distribution between groups | Diagnostic test | Normal control, Patients with GI bleeding |
Primary outcome
VOC Patterns
Time frame: 1 day of 1st emergency room (ER) visit for GI bleeding
Patterns of volatile organic compounds recognized by sensor array
2 secondary outcomes
Measurement of VOC
Time frame: 1 day of 1st emergency room (ER) visit for GI bleeding
Change of VOC patterns
Time frame: 2nd visit (about 2weeks apart from 1st visit)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
HYUNSOO CHUNG, M.D. study chair
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Hemorrhage and Volatile Organic Compounds, run by Seoul National University Hospital at 1 site in South Korea.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact JIN JU CHOI, M.D. (01028087284, wallet87@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VOC Patterns (time frame: 1 day of 1st emergency room (ER) visit for GI bleeding). 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 13 Jan 2020.