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Gastric Mucosal Changes in Patients With Dermatomyositis

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05402670
Collaborator
(none)
150
Enrollment
1
Location
12
Anticipated Duration (Months)
12.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    150 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Gastric Mucosal Changes in Patients With Dermatomyositis
    Anticipated Study Start Date :
    Jun 1, 2022
    Anticipated Primary Completion Date :
    Jun 1, 2023
    Anticipated Study Completion Date :
    Jun 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Dermatomyositis group

    patient with dermatomyositis
    control group

    health check-up population

    Outcome Measures

    Primary Outcome Measures

    1. Gastric mucosal manifestations [1 year]

      Normal gastric mucosa、chronic superficial gastritis、chronic atrophic gastritis、intestinal metaplasia、dysplasia、gastric cancer、gastric ulcer and so on

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Second Affiliated Hospital of Zhejiang University School of Medicine Hangzhou Zhejiang China

    Sponsors and Collaborators

    • Second Affiliated Hospital, School of Medicine, Zhejiang University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Second Affiliated Hospital, School of Medicine, Zhejiang University
    ClinicalTrials.gov Identifier:
    NCT05402670
    Other Study ID Numbers:
    • 2021-0656
    First Posted:
    Jun 2, 2022
    Last Update Posted:
    Jun 2, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Dermatomyositis

    Study Results

    No Results Posted as of Jun 2, 2022