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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000040587
Receipt No. R000046321
Scientific Title The analysis of COVID-19 in saliva, gastric fluid and intestinal fluid on gastrointestinal endoscopy
Date of disclosure of the study information 2020/06/01
Last modified on 2021/02/27

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Basic information
Public title The analysis of COVID-19 in saliva, gastric fluid and intestinal fluid on gastrointestinal endoscopy
Acronym The analysis of COVID-19 on gastrointestinal endoscopy
Scientific Title The analysis of COVID-19 in saliva, gastric fluid and intestinal fluid on gastrointestinal endoscopy
Scientific Title:Acronym The analysis of COVID-19 on gastrointestinal endoscopy
Region
Japan

Condition
Condition Participants who receive endoscopy
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the positive rate of COVID-19 in saliva, gastric fluid and intestinal fluid on gastrointestinal endoscopy
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The positive rate of COVID-19 in saliva, gastric fluid and intestinal fluid on gastrointestinal endoscopy
Key secondary outcomes The value of COVID-19 antibody
The purpose of endoscopy
The patients background

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 The all patients who receive endoscopy
Key exclusion criteria COVID-19 suspected from questionnaire and medical interview
Not willing to participate this study
Emergency endoscopy
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Takuma
Middle name
Last name HIGURASHI
Organization Yokohama City University
Division name Department of gastroenterology and hepatology
Zip code 236-0004
Address 3-9 Fukuura, Kanazawaku, Yokohama, Kanagawa, Japan
TEL 045-787-2800
Email takuma_h@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name Takuma
Middle name
Last name HIGURASHI
Organization Yokohama City University
Division name Department of gastroenterology and hepatology
Zip code 222-0037
Address 3-9 Fukuura, Kanazawaku, Yokohama, Kanagawa, Japan
TEL 045-787-2800
Homepage URL
Email takuma_h@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University
Institute
Department

Funding Source
Organization Yokohama City University
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 Yokohama City University Hospital IRB
Address 3-9 Fukuura, Kanazawaku, Yokohama, Kanagawa, Japan
Tel 045-787-2800
Email rinri@yokohama-cu.ac.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
2020 Year 06 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://doi.org/10.1111/den.13945
Number of participants that the trial has enrolled 792
Results Results: A total of 783 samples (560 upper GIE and 223 lower GIE samples) were analyzed. Polymerase chain reaction (PCR) on saliva samples did not show any positive results in either upper or lower GIE samples. However, 2.0% (16/783) of gastrointestinal fluid samples tested positive for SARS-CoV-2. No significant differences in age, sex, purpose of endoscopy, medication, or rate of antibody test positivity were found between PCR positive and PCR negative cases.
Results date posted
2021 Year 02 Month 27 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2021 Year 02 Month 06 Day
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2020 Year 05 Month 13 Day
Date of IRB
2020 Year 05 Month 13 Day
Anticipated trial start date
2020 Year 06 Month 01 Day
Last follow-up date
2020 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
2020 Year 08 Month 31 Day
Date analysis concluded
2020 Year 09 Month 14 Day

Other
Other related information Observational study

Management information
Registered date
2020 Year 05 Month 29 Day
Last modified on
2021 Year 02 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046321

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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