UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024456 |
|---|---|
| Receipt number | R000028148 |
| Scientific Title | Difference in prevalence of Helicobacter pylori infection in between patients with hemodialysis and normal renal function |
| Date of disclosure of the study information | 2016/10/18 |
| Last modified on | 2016/10/18 11:51:20 |
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Basic information
Public title
Difference in prevalence of Helicobacter pylori infection in between patients with hemodialysis and normal renal function
Acronym
Difference in prevalence of H.pylori infection in hemodialysis patients
Scientific Title
Difference in prevalence of Helicobacter pylori infection in between patients with hemodialysis and normal renal function
Scientific Title:Acronym
Difference in prevalence of H.pylori infection in hemodialysis patients
Region
| Japan |
Condition
Condition
Helicobacter pylori infection
Classification by specialty
| Gastroenterology | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the prevalence of Helicobacter pylori infection in between patients with hemodialysis and normal renal function.
Basic objectives2
Others
Basic objectives -Others
To compare the endoscopic finding in between patients with hemodialysis and normal renal function.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Prevalence of Helicobacter pylori infection in between hemodailysis group and normal renal function group.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who received a gastrointestinal endoscopy and rapid urease test or gastric mucosal biopsy for a diagnosis of Helicobacter pylori infection at Sato Hospital, between June, 2007 and December, 2013.
Key exclusion criteria
The criterion for the control group is the serum creatinine level less than 1.5 mg/dL.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Morita |
Organization
Gifu University Graduate School of Medicine
Division name
Department of General Internal Medicine
Zip code
Address
1-1 Yanagido, Gifu
TEL
058-230-6632
hmorita@gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noriko Takahashi |
Organization
Gifu University Graduate School of Medicine
Division name
Department of General Internal Medicine
Zip code
Address
1-1 Yanagido, Gifu
TEL
058-230-6632
Homepage URL
dora_bokuemonn0427@yahoo.co.jp
Sponsor or person
Institute
Gifu University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 10 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 10 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 10 | Month | 18 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Performing a retrospective observational study based on the medical record information in patients who received a gastrointestinal endoscopy and rapid urease test or gastric mucosal biopsy at Sato hospital between January, 2007 and December, 2013.
Management information
Registered date
| 2016 | Year | 10 | Month | 18 | Day |
Last modified on
| 2016 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028148
