UMIN-CTR Clinical Trial

Basic information
Public title	Usefulness of PCR testing for COVID-19 before gastrointestinal endoscopy and hospitalization
Acronym	Usefulness of PCR testing for COVID-19 before gastrointestinal endoscopy and hospitalization
Scientific Title	Usefulness of PCR testing for SARS-CoV-2 before gastrointestinal endoscopy and hospitalization
Scientific Title:Acronym	Usefulness of PCR testing for SARS-CoV-2 before gastrointestinal endoscopy and hospitalization
Region	Japan

Condition
Condition	COVID-19
Classification by specialty	Gastroenterology Hepato-biliary-pancreatic medicine Infectious disease
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim is to investigate the utility of PCR testing for COVID-19 before gastrointestinal endoscopy and before hospitalization.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The positive rate of PCR test for COVID-19 before gastrointestinal endoscopy and before hospitalization.
Key secondary outcomes	Questionnaires will be administered to patients and health care providers to evaluate the mental aspect of performing PCR testing for COVID-19 prior to gastrointestinal endoscopy.

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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients who have undergone COVID-19 PCR testing before admission and gastrointestinal endoscopy at our hospital and who have obtained consent.
Key exclusion criteria	Cases in which consent was not obtained and cases deemed unsuitable by the study physician will be excluded from the study.
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Naoya Middle name Last name Kato
Organization	Graduate School of Medicine, Chiba University
Division name	Department of Gastroenterology
Zip code	260-8670
Address	1-8-1, Inohana, Chuo Ward, Chiba-shi, Chiba
TEL	+81-43-226-2083
Email	ohta.yuki@chiba-u.jp

Public contact
Name of contact person	1st name Yuki Middle name Last name Ohta
Organization	Graduate School of Medicine, Chiba University
Division name	Department of Gastroenterology
Zip code	260-8670
Address	1-8-1, Inohana, Chuo Ward, Chiba-shi, Chiba
TEL	+81-43-226-2083
Homepage URL
Email	ohta.yuki@chiba-u.jp

Sponsor
Institute	Chiba University
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Research ethics committee of the graduate school of medicine, Chiba university
Address	1-8-1, Inohana, Chuo Ward, Chiba-shi, Chiba
Tel	043-222-7171
Email	inohana-rinri@chiba-u.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 05 Month 26 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	2020 Year 05 Month 22 Day
Date of IRB	2020 Year 05 Month 22 Day
Anticipated trial start date	2023 Year 03 Month 31 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	None

Management information
Registered date	2020 Year 05 Month 26 Day
Last modified on	2020 Year 05 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046253