Peptic UlcerNCT04636866
The Prevalence of Helicobacter Pylori in Shanghai, 2013 to 2019
An observational study of Peptic Ulcer and Helicobacter Pylori Infection, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
The study was a cross-sectional single-center study, conducted at Renji Hospital, Shanghai Jiaotong university school of medicine. We retrieved the medical records of all patients who had undergone upper gastrointestinal endoscopy from January 1, 2013 through December 31, 2019. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Peptic Ulcer, Helicobacter Pylori Infection
- How many people
- 400,000 participants
- Where
- 1 siteChina
- Study dates
- 10 Feb 2020to 16 Sep 2020
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: We retrieved the medical records of all patients who had undergone upper gastrointestinal endoscopy because of uninvestigated dyspepsia from January 1, 2013 through December 31, 2019.
Who may be able to join
- All patients who had undergone upper gastrointestinal endoscopy in Renji Hospital because of uninvestigated dyspepsia during 2013 and 2019 were analyzed.
Who cannot join
- Patients that underwent upper endoscopy for reasons other than uninvestigated dyspepsia such as cirrhosis follow-up, major systemic diseases or other indications were excluded. Exclusions also included absence of biopsies, unknown H. pylori status and acute ulcer bleeding.
Trial locations and contacts
1 site in 1 country.
China1 site
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200127
About this study
Official title: The Prevalence of Helicobacter Pylori Infection in Patients With Peptic Ulcer Disease in Shanghai, 2013 to 2019
The study was a cross-sectional single-center study, conducted at Renji Hospital, Shanghai Jiaotong university school of medicine. We retrieved the medical records of all patients who had undergone upper gastrointestinal endoscopy from January 1, 2013 through December 31, 2019. The medical records were analyzed for the prevalence of H. pylori infection in patients with peptic ulcers.
- Conditions
- Peptic Ulcer, Helicobacter Pylori Infection
- Being tested
- NO intervention
- Medical subject headings
- Peptic Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NO interventionOther
NO intervention
| Study group | Role | What they receive |
|---|---|---|
| Gastric ulcer | Not described Receives: Other: NO intervention | |
| Duodenal ulcer | Not described Receives: Other: NO intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
the prevalence of Helicobacter pylori and peptic ulcer
the trends change from 2013 to 2019
Measured: 2013.1.1-2019.12.31
the ration of Helicobacter pylori positive peptic ulcers
the trends change from 2013 to 2019
Measured: 2013.1.1-2019.12.31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start10 Feb 2020
- Primary completion21 Jul 2020
- Study completion16 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peptic UlcerStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- 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 only
- Time perspective
- Retrospective
- Enrolment
- 400,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hong Lu, MD, Shanghai Jiao Tong University School of Medicine
- Investigators
- HONG LU, PhD, Study director, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04636866
- Sponsor's protocol ID
- shrj202010171
- Status last verified
- Nov 2020
- First submitted
- 14 Nov 2020
- Last updated
- 19 Nov 2020
- 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 19 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence of Helicobacter Pylori Infection in Patients With Peptic Ulcer Disease in Shanghai, 2013 to 2019
- ClinicalTrials.gov ID
- NCT04636866
- Acronym / sponsor ID
- shrj202010171
- Conditions
- Peptic Ulcer, Helicobacter Pylori Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400,000 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 10 Feb 2020 (actual)
- Primary completion
- 21 Jul 2020 (actual)
- Study completion
- 16 Sep 2020 (actual)
- First posted
- 19 Nov 2020 (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.
The study was a cross-sectional single-center study, conducted at Renji Hospital, Shanghai Jiaotong university school of medicine. We retrieved the medical records of all patients who had undergone upper gastrointestinal endoscopy from January 1, 2013 through December 31, 2019. The medical records were analyzed for the prevalence of H. pylori infection in patients with peptic ulcers.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gastric ulcer | – | Other: NO intervention |
| Duodenal ulcer | – | Other: NO intervention |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- We retrieved the medical records of all patients who had undergone upper gastrointestinal endoscopy because of uninvestigated dyspepsia from January 1, 2013 through December 31, 2019.
Key inclusion criteria (1 listed)
- All patients who had undergone upper gastrointestinal endoscopy in Renji Hospital because of uninvestigated dyspepsia during 2013 and 2019 were analyzed.
Key exclusion criteria (1 listed)
- Patients that underwent upper endoscopy for reasons other than uninvestigated dyspepsia such as cirrhosis follow-up, major systemic diseases or other indications were excluded. Exclusions also included absence of biopsies, unknown H. pylori status and acute ulcer bleeding.
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 |
|---|---|---|
| NO interventionNO intervention | Other | Duodenal ulcer, Gastric ulcer |
Primary outcome
the prevalence of Helicobacter pylori and peptic ulcer
Time frame: 2013.1.1-2019.12.31
the trends change from 2013 to 2019
the ration of Helicobacter pylori positive peptic ulcers
Time frame: 2013.1.1-2019.12.31
the trends change from 2013 to 2019
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2020.
- Individual participant dataSharing planned: No
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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.
HONG LU, PhD study director
RenJi Hospital
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 Peptic Ulcer and Helicobacter Pylori Infection, run by Shanghai Jiao Tong 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 1 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: finished, as of the sponsor's last update on 19 Nov 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the prevalence of Helicobacter pylori and peptic ulcer (time frame: 2013.1.1-2019.12.31). The study lists 2 primary outcomes in all. 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 19 Nov 2020.