UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032668 |
|---|---|
| Receipt number | 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 15:16:25 |
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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
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
fuk.naga.23@gmail.com
Sponsor or person
Institute
Nagasaki University Hospital
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
Nagasaki University Hospital
Address
1-7-1 Sakamoto,Nagasaki
Tel
095-819-7481
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037249
