Gastric Mucosal Manifestations in Patients With DermatomyositisNCT05402670
Gastric Mucosal Changes in Patients With Dermatomyositis
An observational study of Gastric Mucosal Manifestations in Patients With Dermatomyositis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastric Mucosal Manifestations in Patients With Dermatomyositis
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2022to 1 Jun 2023
- 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: 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。
Who may be able to join
- 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 .
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang
han yuehua, +86 0571 89713734, 13858126927@163.com
About this study
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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
| Study group | Role | What they receive |
|---|---|---|
| Dermatomyositis group | patient with dermatomyositis | |
| control group | health check-up population |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric mucosal manifestations
Normal gastric mucosa、chronic superficial gastritis、chronic atrophic gastritis、intestinal metaplasia、dysplasia、gastric cancer、gastric ulcer and so on
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start1 Jun 2022 (estimated)
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Mucosal Manifestations in Patients With DermatomyositisStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05402670
- Sponsor's protocol ID
- 2021-0656
- Status last verified
- May 2022
- First submitted
- 8 Nov 2021
- Last updated
- 2 Jun 2022
- Results posted
- No
- 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 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastric Mucosal Changes in Patients With Dermatomyositis
- ClinicalTrials.gov ID
- NCT05402670
- Acronym / sponsor ID
- 2021-0656
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jun 2022 (estimated)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 2 Jun 2022 (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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dermatomyositis group | – | –patient with dermatomyositis |
| control group | – | –health check-up population |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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。
Key inclusion criteria (1 listed)
- 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 .
Key exclusion criteria (3 listed)
- Contraindications for gastroscopy.
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 |
|---|---|---|
| Other | Dermatomyositis group, control group |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2022.
- Individual participant dataSharing planned: No
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.
Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, 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 Mucosal Manifestations in Patients With Dermatomyositis, 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 1 inclusion and 3 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 2 Jun 2022. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastric mucosal manifestations (time frame: 1 year). 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 2 Jun 2022; AzTrials last refreshed its copy on 1 Nov 2026.