- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04037904
Long-term Follow-up of Interleukin-1B and H+,K+-ATPase mRNA Expression After Helicobacter Pylori Eradication
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Nayoung Kim, M.D., Ph.D.
- Phone Number: +82-31-787-7008
- Email: nayoung49@empas.com
Study Locations
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Gyeonggi-do
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Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
- Seoul National University Bundang Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Controls who did not have any evidence of gastric cancer, gastric dysplasia, esophageal tumor, peptic ulcer and lymphoma on esophagogastroduodenoscopy
- Patients with gastric dysplasia or gastric cancer who diagnosed with gastric dysplasia or early gastric cancer in the final pathological report
Exclusion Criteria:
- Subjects with previous eradication treatment for H. pylori
- Subjects with previous gastrectomy
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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H. pylori negative group
Subjects who have not have H. pylori infection, and had not receive H. pylori eradication
|
H. pylorieradicated group
Subjects who have had H. pylori infection currently and received successful H. pylori eradication according to appropriated indication
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Interleukin-1B and H+,K+-ATPase mRNA expression
Time Frame: 1 year
|
Gastric Interleukin-1B and H+,K+-ATPase mRNA expression in subjects with and without H. pylori infection at baseline, and changes of Interleukin-1B and H+,K+-ATPase mRNA expression with time in subjects without H. pylori infection and subjects who underwent H. pylori eradication successfully. Gastric Interleukin-1B and H+,K+-ATPase mRNA expression measured by reverse transcription polymerase chain reaction, using the gastric mucosa specimen obtained during esophagogastroduodenoscopy |
1 year
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- B-1509/316-302
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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