NCT04636866

Brief 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. The medical records were analyzed for the prevalence of H. pylori infection in patients with peptic ulcers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 10, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 14, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 19, 2020

Completed
Last Updated

November 19, 2020

Status Verified

November 1, 2020

Enrollment Period

5 months

First QC Date

November 14, 2020

Last Update Submit

November 14, 2020

Conditions

Peptic UlcerHelicobacter Pylori Infection

Outcome Measures

Primary Outcomes (2)

  • the prevalence of Helicobacter pylori and peptic ulcer

    the trends change from 2013 to 2019

    2013.1.1-2019.12.31

  • the ration of Helicobacter pylori positive peptic ulcers

    the trends change from 2013 to 2019

    2013.1.1-2019.12.31

Study Arms (2)

Gastric ulcer

Other: NO intervention

Duodenal ulcer

Other: NO intervention

Interventions

NO interventionOTHER

NO intervention

Duodenal ulcerGastric ulcer

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • All patients who had undergone upper gastrointestinal endoscopy in Renji Hospital because of uninvestigated dyspepsia during 2013 and 2019 were analyzed.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200127, China

Location

MeSH Terms

Conditions

Peptic Ulcer

Condition Hierarchy (Ancestors)

Duodenal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesStomach Diseases

Study Officials

  • HONG LU, PhD

    RenJi Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

November 14, 2020

First Posted

November 19, 2020

Study Start

February 10, 2020

Primary Completion

July 21, 2020

Study Completion

September 16, 2020

Last Updated

November 19, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)