Gastric CancerNCT04624282
Metabonomics Study of Chronic Gastritis and Gastric Carcinoma
An observational study of Gastric Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- different diseases
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2020to 31 May 2021
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We will enroll patients with chronic superficial gastritis, chronic atrophic gastritis or gastric carcinoma.
Who may be able to join
- Patients with chronic superficial gastritis and chronic atrophic gastritis
- Patients with gastric carcinoma
Who cannot join
- Patients with history of surgery
- Patients with severe heart disease,lung disease or kidney disease.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
2nd Affiliated Hospital, School of Medicine
Hangzhou, Zhejiang University, 310000
Yuehua Han, Docter, 86-0571-87783563, 13858126927@163.com
About this study
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.
Read the 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.
- Conditions
- Gastric Cancer
- Being tested
- different diseases
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
different diseasesDiagnostic test
Patients will be divided into three groups, including chronic superficial gastritis ,chronic atrophic gastritis and gastric carcinoma.
| Study group | Role | What they receive |
|---|---|---|
| Patients with chronic superficial gastritis | Patients with chronic superficial gastritis Receives: Diagnostic Test: different diseases | |
| Patients with chronic atrophic gastritis | Patients with chronic atrophic gastritis Receives: Diagnostic Test: different diseases | |
| Patients with gastric carcinoma | Patients with gastric carcinoma Receives: Diagnostic Test: different diseases |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabonomic difference in patients with chronic gastritis and gastric carcinoma
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.
Measured: six months
Secondary outcomes (1)
Association of different metabolic substances and disease results in chronic gastritis and gastric carcinoma
The researchers want to reveal the relationship between different metabolic sustances and disease result in patientswith chronic gastritis and gastric carcinoma.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study start1 Nov 2020
- Primary completion30 Apr 2021 (estimated)
- Study completion31 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanyuehua, Second Affiliated Hospital, Zhejiang University, School of Medicine
- Investigators
- Yuehua Han, Dr., Principal investigator, 2nd Affiliated Hospital, School of Medicine, Zhejiang university, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04624282
- Sponsor's protocol ID
- I2020001797
- Status last verified
- Jan 2021
- First submitted
- 19 Oct 2020
- Last updated
- 20 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabonomics Study of Chronic Gastritis and Gastric Carcinoma
- ClinicalTrials.gov ID
- NCT04624282
- Acronym / sponsor ID
- I2020001797
- Conditions
- Gastric Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 30 Apr 2021 (estimated)
- Study completion
- 31 May 2021 (estimated)
- First posted
- 10 Nov 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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with chronic superficial gastritis | – | Diagnostic Test: different diseasesPatients with chronic superficial gastritis |
| Patients with chronic atrophic gastritis | – | Diagnostic Test: different diseasesPatients with chronic atrophic gastritis |
| Patients with gastric carcinoma | – | Diagnostic Test: different diseasesPatients with gastric carcinoma |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We will enroll patients with chronic superficial gastritis, chronic atrophic gastritis or gastric carcinoma.
Key inclusion criteria (2 listed)
- Patients with chronic superficial gastritis and chronic atrophic gastritis
- Patients with gastric carcinoma
Key exclusion criteria (2 listed)
- Patients with history of surgery
- Patients with severe heart disease,lung disease or kidney disease.
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 |
|---|---|---|
| different diseasesPatients will be divided into three groups, including chronic superficial gastritis ,chronic atrophic gastritis and gastric carcinoma. | Diagnostic test | Patients with chronic atrophic gastritis, Patients with chronic superficial gastritis, Patients with gastric carcinoma |
Primary outcome
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.
1 secondary outcome
Association of different metabolic substances and disease results in chronic gastritis and gastric carcinoma
Time frame: six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
- Individual participant dataSharing planned: No
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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.
Yuehua Han, Dr. principal investigator
2nd Affiliated Hospital, School of Medicine, Zhejiang university, China
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 Gastric Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 2 inclusion and 2 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 20 Jan 2021. 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 Yuehua Han, Dr. (+86 13858126927, 13858126927@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabonomic difference in patients with chronic gastritis and gastric carcinoma (time frame: six months). 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 20 Jan 2021.