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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000022631
Receipt No. 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

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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
Email 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
Email a-yamauchi@kitano-hp.or.jp

Sponsor
Institute Digestive Disease Center, Kitano Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026089

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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