Gastric Mucosal Changes in Patients With Dermatomyositis

May 30, 2022 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
There are a large number of reports in the literature that patients with dermatomyositis often have various malignant tumors, and reports of gastric cancer are not rare. At present, the widely recognized gastric cancer occurrence patterns are: normal gastric mucosa-chronic superficial gastritis-chronic atrophic gastritis-intestinal metaplasia-dysplasia-gastric cancer, so the research about the gastric mucosal performance of patients with dermatomyositis is clinically meaningful

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • Second Affiliated Hospital of Zhejiang University School of Medicine
        • Contact:

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

Probability Sample

Study Population

Dermatomyositis patients in the Department of Rheumatology, the Second Affiliated Hospital of Zhejiang University School of Medicine。 Healthy people undergoing physical examination at the Physical Examination Center of the Second Affiliated Hospital of Zhejiang University School of Medicine。

Description

Inclusion Criteria:

  • 1、18-70years old，no gender limit. 2、Clinical diagnosis of dermatomyositis. 3、dermatomyositis group conform to 1 and 2，control group conform to 1 .

Exclusion Criteria:

  • Contraindications for gastroscopy.

    • Past history of malignant tumors of the esophagus and stomach and or history of surgery.

      • Pregnant or lactating women. ④ Participated in other clinical studies within 3 months. ⑤Patients cannot express their main complaints correctly and cannot cooperate with the research.

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

Cohorts and Interventions

Group / Cohort
Dermatomyositis group
patient with dermatomyositis
control group
health check-up population

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastric mucosal manifestations
Time Frame: 1 year
Normal gastric mucosa、chronic superficial gastritis、chronic atrophic gastritis、intestinal metaplasia、dysplasia、gastric cancer、gastric ulcer and so on
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

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 (ANTICIPATED)

June 1, 2022

Primary Completion (ANTICIPATED)

June 1, 2023

Study Completion (ANTICIPATED)

June 1, 2023

Study Registration Dates

First Submitted

November 8, 2021

First Submitted That Met QC Criteria

May 30, 2022

First Posted (ACTUAL)

June 2, 2022

Study Record Updates

Last Update Posted (ACTUAL)

June 2, 2022

Last Update Submitted That Met QC Criteria

May 30, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-0656

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.

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