Upper GI BleedingNCT05457062
Analysis the Vocs in Upper GI Bleeding Patients
An observational study of Upper GI Bleeding, run by Affiliated Hospital to Academy of Military Medical Sciences at 1 site in China.
Trial summary
This project aims to collect the exhaled breath of patients with acute upper gastrointestinal bleeding clinically, divide them into large, small and no bleeding groups according to the results of gastroscopy, analyze the characteristics of volatile organic compound components in exhaled breath, construct a… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Upper GI Bleeding
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 4 Jul 2022to Jun 2023
- How long will I take part?
- 6 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: upper GI bleeding patients who will under go endoscopy examination
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the Fifth Medical Center of Chinese PLA General Hospital
Beijing, Beijing Municipality, 100071
Yan Liu, Ph.D., 010-66947473, 13911798288@163.com
About this study
Official title: Study Based on Volatile Organic Compounds Analysis in Patients With Acute Upper Gastrointestinal Bleeding
This project aims to collect the exhaled breath of patients with acute upper gastrointestinal bleeding clinically, divide them into large, small and no bleeding groups according to the results of gastroscopy, analyze the characteristics of volatile organic compound components in exhaled breath, construct a discriminant model, and then analyze the sensitivity and specificity, and the target sensitivity and specificity reach more than 0.7, and formulate diagnostic criteria.
Read the detailed description
Upper gastrointestinal bleeding is one of the most common gastrointestinal emergencies and has a high mortality rate. Its clinical manifestations are hematemesis and melena, gastroscopy is the gold standard for diagnosing upper gastrointestinal bleeding, but due to its expensive equipment, long training cycle of personnel, gastroscopy itself is an invasive operation, poor patient tolerance, high risk of examination, often lead to the diagnosis of upper gastrointestinal bleeding is not timely, missing the best treatment time. Volatile organic compound analysis in exhalation is based on the patient's metabolic component analysis technology, a new means of disease diagnosis, due to its advantages of convenient collection, non-invasive, rapid detection, etc., it has been applied in the diagnosis of various diseases such as drunken screening and Helicobacter pylori infection, but has not been studied in the diagnosis of upper gastrointestinal bleeding. This project aims to collect the exhaled breath of patients with acute upper gastrointestinal bleeding clinically, divide them into large, small and no bleeding groups according to the results of gastroscopy, analyze the characteristics of volatile organic compound components in exhaled breath, construct a discriminant model, and then analyze the sensitivity and specificity, and the target sensitivity and specificity reach more than 0.7, and formulate diagnostic criteria. This study will improve the timeliness of upper GI bleeding detection, which is of great significance for effectively reducing the mortality rate of upper GI bleeding.
- Conditions
- Upper GI Bleeding
- Medical subject headings
- Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| large amount of bleeding | large amount of upper GI bleeding after EGD identified | |
| no bleeding | no upper GI bleeding after EGD identified | |
| small amount of bleeding | small amount of upper GI bleeding after EGD identified |
What is being measured
The primary outcome is the main question the study is designed to answer.
death in hospital
all cause death in hospital
Measured: 6 weeks
Secondary outcomes (1)
rebleeding
rebleeding in five days
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start4 Jul 2022
- Primary completionDec 2022 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper GI BleedingStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 6 Weeks
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital to Academy of Military Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05457062
- Sponsor's protocol ID
- vocs in upper GI bleeding
- Status last verified
- Jun 2022
- First submitted
- 9 Jul 2022
- Last updated
- 13 Jul 2022
- 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 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Based on Volatile Organic Compounds Analysis in Patients With Acute Upper Gastrointestinal Bleeding
- ClinicalTrials.gov ID
- NCT05457062
- Acronym / sponsor ID
- vocs in upper GI bleeding
- Conditions
- Upper GI Bleeding
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Affiliated Hospital to Academy of Military Medical SciencesUniversity, hospital or other
- Study start
- 4 Jul 2022 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 13 Jul 2022 (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 project aims to collect the exhaled breath of patients with acute upper gastrointestinal bleeding clinically, divide them into large, small and no bleeding groups according to the results of gastroscopy, analyze the characteristics of volatile organic compound components in exhaled breath, construct a discriminant model, and then analyze the sensitivity and specificity, and the target sensitivity and specificity reach more than 0.7, and formulate diagnostic criteria.
Detailed description
Upper gastrointestinal bleeding is one of the most common gastrointestinal emergencies and has a high mortality rate. Its clinical manifestations are hematemesis and melena, gastroscopy is the gold standard for diagnosing upper gastrointestinal bleeding, but due to its expensive equipment, long training cycle of personnel, gastroscopy itself is an invasive operation, poor patient tolerance, high risk of examination, often lead to the diagnosis of upper gastrointestinal bleeding is not timely, missing the best treatment time. Volatile organic compound analysis in exhalation is based on the patient's metabolic component analysis technology, a new means of disease diagnosis, due to its advantages of convenient collection, non-invasive, rapid detection, etc., it has been applied in the diagnosis of various diseases such as drunken screening and Helicobacter pylori infection, but has not been studied in the diagnosis of upper gastrointestinal bleeding. This project aims to collect the exhaled breath of patients with acute upper gastrointestinal bleeding clinically, divide them into large, small and no bleeding groups according to the results of gastroscopy, analyze the characteristics of volatile organic compound components in exhaled breath, construct a discriminant model, and then analyze the sensitivity and specificity, and the target sensitivity and specificity reach more than 0.7, and formulate diagnostic criteria. This study will improve the timeliness of upper GI bleeding detection, which is of great significance for effectively reducing the mortality rate of upper GI bleeding.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Weeks
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| large amount of bleeding | – | –large amount of upper GI bleeding after EGD identified |
| no bleeding | – | –no upper GI bleeding after EGD identified |
| small amount of bleeding | – | –small amount of upper GI bleeding after EGD identified |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- upper GI bleeding patients who will under go endoscopy examination
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
death in hospital
Time frame: 6 weeks
all cause death in hospital
1 secondary outcome
rebleeding
Time frame: 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2022.
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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.
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 Upper GI Bleeding, run by Affiliated Hospital to Academy of Military Medical Sciences at 1 site in China.
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 0 inclusion and 1 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 Jul 2022. 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 China. 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 Qian Bi, phD (66933216, 381021791@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
death in hospital (time frame: 6 weeks). 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 Jul 2022; AzTrials last refreshed its copy on 26 Oct 2026.