NCT04624282

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 19, 2020

Completed
13 days until next milestone

Study Start

First participant enrolled

November 1, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 10, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
Last Updated

January 20, 2021

Status Verified

January 1, 2021

Enrollment Period

6 months

First QC Date

October 19, 2020

Last Update Submit

January 17, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    six months

Secondary Outcomes (1)

  • Association of different metabolic substances and disease results in chronic gastritis and gastric carcinoma

    six months

Study Arms (3)

Patients with chronic superficial gastritis

Patients with chronic superficial gastritis

Diagnostic Test: different diseases

Patients with chronic atrophic gastritis

Patients with chronic atrophic gastritis

Diagnostic Test: different diseases

Patients with gastric carcinoma

Patients with gastric carcinoma

Diagnostic Test: different diseases

Interventions

different diseasesDIAGNOSTIC_TEST

Patients will be divided into three groups, including chronic superficial gastritis ,chronic atrophic gastritis and gastric carcinoma.

Patients with chronic atrophic gastritisPatients with chronic superficial gastritisPatients with gastric carcinoma

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

We will enroll patients with chronic superficial gastritis, chronic atrophic gastritis or gastric carcinoma.

You may qualify if:

  • Patients with chronic superficial gastritis and chronic atrophic gastritis
  • Patients with gastric carcinoma

You may not qualify if:

  • Patients with history of surgery
  • Patients with severe heart disease,lung disease or kidney disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

2nd Affiliated Hospital, School of Medicine

Hangzhou, Zhejiang University, 310000, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Yuehua Han, Dr.

    2nd Affiliated Hospital, School of Medicine, Zhejiang university, China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief physician

Study Record Dates

First Submitted

October 19, 2020

First Posted

November 10, 2020

Study Start

November 1, 2020

Primary Completion

April 30, 2021

Study Completion

May 31, 2021

Last Updated

January 20, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations