- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04624282
Metabonomics Study of Chronic Gastritis and Gastric Carcinoma
January 17, 2021 updated by: Hanyuehua, Second Affiliated Hospital, School of Medicine, Zhejiang University
The pathogenetic mechanisms of chronic gastritis and gastric carcinoma are different.
Whether metabonomics play a role in the development of chronic gastritis and gastric cancer is still a question.
So the investigators want to clarify this question by this subject.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
This project was an untargeted metabolomics study using liquid chromatography coupled with mass spectrometry (LC-MS) in patients with chronic gastritis and gastric carcinoma.
The experimental procedures mainly include sample collection, metabolite extraction, LC-MS/MS detection, data analysis, etc.The goal of this study is to identify and (relatively) quantify as many metabolites in biological systems as possible, so as to reveal the overall metabolite information to the maximum extent.
Metabolomics aims to investigate the changes of metabolites in gastric tissues in patients with chronic gastritis and gastric carcinoma, and to study the biological processes in which these metabolites participate by screening the different metabolites in the different groups, and to reveal the mechanism of life activities in which they involved in.
Study Type
Observational
Enrollment (Anticipated)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yuehua Han, Dr.
- Phone Number: +86 13858126927
- Email: 13858126927@163.com
Study Locations
-
-
Zhejiang University
-
Hangzhou, Zhejiang University, China, 310000
- Recruiting
- 2nd Affiliated Hospital, School of Medicine
-
Contact:
- Yuehua Han, Docter
- Phone Number: 86-0571-87783563
- Email: 13858126927@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
We will enroll patients with chronic superficial gastritis, chronic atrophic gastritis or gastric carcinoma.
Description
Inclusion Criteria:
- Patients with chronic superficial gastritis and chronic atrophic gastritis
- Patients with gastric carcinoma
Exclusion Criteria:
- Patients with history of surgery
- Patients with severe heart disease,lung disease or kidney disease.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients with chronic superficial gastritis
|
Patients will be divided into three groups, including chronic superficial gastritis ,chronic atrophic gastritis and gastric carcinoma.
|
|
Patients with chronic atrophic gastritis
|
Patients will be divided into three groups, including chronic superficial gastritis ,chronic atrophic gastritis and gastric carcinoma.
|
|
Patients with gastric carcinoma
|
Patients will be divided into three groups, including chronic superficial gastritis ,chronic atrophic gastritis and gastric carcinoma.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Metabonomic difference in patients with chronic gastritis and gastric carcinoma
Time Frame: six months
|
1.The different levels of metabolites in gastric tissues in patients with chronic gastritis and gastric carcinoma.
2. The common change model of metabolites in gastric carcionoma compared with chronic gastritis.
|
six months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Association of different metabolic substances and disease results in chronic gastritis and gastric carcinoma
Time Frame: six months
|
The researchers want to reveal the relationship between different metabolic sustances and disease result in patientswith chronic gastritis and gastric carcinoma.
|
six months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Yuehua Han, Dr., 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2020
Primary Completion (Anticipated)
April 30, 2021
Study Completion (Anticipated)
May 31, 2021
Study Registration Dates
First Submitted
October 19, 2020
First Submitted That Met QC Criteria
November 5, 2020
First Posted (Actual)
November 10, 2020
Study Record Updates
Last Update Posted (Actual)
January 20, 2021
Last Update Submitted That Met QC Criteria
January 17, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- I2020001797
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.