UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022631 |
|---|---|
| Receipt number | R000026089 |
| Scientific Title | Rapid urease test using gastric mucus for diagnosis of Helicobacter pylori |
| Date of disclosure of the study information | 2016/06/06 |
| Last modified on | 2019/12/09 16:53:25 |
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Basic information
Public title
Rapid urease test using gastric mucus for diagnosis of Helicobacter pylori
Acronym
RUT using gastric mucus
Scientific Title
Rapid urease test using gastric mucus for diagnosis of Helicobacter pylori
Scientific Title:Acronym
RUT using gastric mucus
Region
| Japan |
Condition
Condition
H. pylori infections
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Detection of H. pylori in gastric mucus
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Concordance rate for RUT using gastric mucosa and gastric mucus
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
| 95 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. performed endoscopy
2. over 20 years old
3. obtained the agreement
Key exclusion criteria
1. eradication of H. pylori
2. taking agents having bacteriostatic action
3. taking antithrombogenic agents
4. gastric bleeding
5. strong vomiting reflex
6. Performance status 1-4
7. serious complication
8. inappropriate case
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Yamauchi |
Organization
Kitano Hospital
Division name
Digestive Disease Center
Zip code
530-8480
Address
2-4-20, Ohgimachi, Kita-ku, Osaka, Japan
TEL
06-6312-1221
a-yamauchi@kitano-hp.or.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Yamauchi |
Organization
Kitano Hospital
Division name
Digestive Disease Center
Zip code
530-8480
Address
2-4-20, Ohgimachi, Kita-ku, Osaka, Japan
TEL
06-6312-1221
Homepage URL
a-yamauchi@kitano-hp.or.jp
Sponsor or person
Institute
Digestive Disease Center, Kitano Hospital
Institute
Department
Personal name
Funding Source
Organization
Institute of Immunology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kawasaki Medical School Hospital
Kawasaki Medical School General Medical Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kitano Hospital
Address
2-4-20 Ohgimachi,Kita-ku
Tel
0663610588
a-yamauchi@kitano-hp.or.jp
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 | 06 | Month | 06 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 02 | Month | 18 | Day |
Anticipated trial start date
| 2016 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observation study
Management information
Registered date
| 2016 | Year | 06 | Month | 06 | Day |
Last modified on
| 2019 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026089
