UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040516 |
|---|---|
| Receipt number | R000046253 |
| Scientific Title | Usefulness of PCR testing for SARS-CoV-2 before gastrointestinal endoscopy and hospitalization |
| Date of disclosure of the study information | 2020/05/26 |
| Last modified on | 2020/05/26 01:08:18 |
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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
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
ohta.yuki@chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046253
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
