UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000032668
Receipt No. R000037249
Scientific Title Rapid detection of Helicobacter pylori infection by g-glutamyltranspeptidase-activated fluorescent probe
Date of disclosure of the study information 2018/05/21
Last modified on 2020/08/22 (Ver. 6)

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Basic information
Public title Rapid detection of Helicobacter pylori infection by g-glutamyltranspeptidase-activated fluorescent probe
Acronym Rapid detection of Helicobacter pylori infection by g-glutamyltranspeptidase-activated fluorescent probe
Scientific Title Rapid detection of Helicobacter pylori infection by g-glutamyltranspeptidase-activated fluorescent probe
Scientific Title:Acronym Rapid detection of Helicobacter pylori infection by g-glutamyltranspeptidase-activated fluorescent probe
Region
Japan

Condition
Condition Helicobacter pylori gastritis
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate whether gGlu-HMRG can be useful for rapid diagnosing H. pylori infection.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Sensitivity and specificity of fluorescent probe gGlu-HMRG for Helicobacter pylori gastritis
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Medicine Other
Interventions/Control_1 Biopsy from the antrum and the stomach of body
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 undergo esophagogastroduodenoscopy in Helicobacter pylori positive gastritis or Helicobacter pylori negative.
Key exclusion criteria Unsuitable patient
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Taro
Middle name
Last name Akashi
Organization Nagasaki University Hospital
Division name Department of GASTROENTEROLOGY and HEPATOLOGY
Zip code 852-8501
Address 1-7-1 Sakamoto,Nagasaki
TEL 095-819-7481
Email fuk.naga.23@gmail.com

Public contact
Name of contact person
1st name Taro
Middle name
Last name Akashi
Organization Nagasaki University Hospital
Division name Department of GASTROENTEROLOGY and HEPATOLOGY
Zip code 852-8501
Address 1-7-1 Sakamoto,Nagasaki
TEL 095-819-7481
Homepage URL
Email fuk.naga.23@gmail.com

Sponsor
Institute Nagasaki University Hospital
Institute
Department

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 Nagasaki University Hospital
Address 1-7-1 Sakamoto,Nagasaki
Tel 095-819-7481
Email fuk.naga.23@gmail.com

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
2018 Year 05 Month 21 Day

Related information
URL releasing protocol https://www.nature.com/articles/s41598-019-45768-x
Publication of results Published

Result
URL related to results and publications https://www.nature.com/articles/s41598-019-45768-x
Number of participants that the trial has enrolled 46
Results 
The gGlu-HMRG assay substantially elucidated H. pylori GGT activity in vitro. 
The ex vivo H. pylori GGT-activatable fluorescence assay is potentially applicable for rapid diagnosis of H. pylori infections.
Results date posted
2020 Year 08 Month 22 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
men 31, women 15.
mean age, 63.8 and 70.1 years, respectively.
Participant flow 
All 46 participants underwent esophagogastroduodenoscopy at Nagasaki University Hospital. One biopsy was taken from the antrum and one from the body of the stomach.
Adverse events 
none
Outcome measures 
We investigated whether gGlu-HMRG was activated by GGT produced by H. pylori cells and emit fluorescence in vitro. An ex vivo imaging assay for GGT activity with gGlu-HMRG was conducted to detect H. pylori infection using clinical samples(biopsy from the antrum and the stomach body ) .
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2015 Year 02 Month 10 Day
Date of IRB
2015 Year 02 Month 10 Day
Anticipated trial start date
2015 Year 02 Month 10 Day
Last follow-up date
2019 Year 07 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 05 Month 21 Day
Last modified on
2020 Year 08 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037249