UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040185 |
|---|---|
| Receipt number | R000045820 |
| Scientific Title | Multicenter prospective cohort study evaluating outcome of COVID-19 in patients with hepatobiliary-pancreatic disease |
| Date of disclosure of the study information | 2020/04/17 |
| Last modified on | 2023/04/24 22:31:15 |
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Basic information
Public title
Multicenter prospective cohort study evaluating outcome of COVID-19 in patients with hepatobiliary-pancreatic disease
Acronym
Multicenter prospective cohort study evaluating outcome of COVID-19 in patients with hepatobiliary-pancreatic disease
Scientific Title
Multicenter prospective cohort study evaluating outcome of COVID-19 in patients with hepatobiliary-pancreatic disease
Scientific Title:Acronym
COVID-19 in patients with hepatobiliary-pancreatic disease
Region
| Japan |
Condition
Condition
COVID-19
Hepatobiliary-pancreatic disease
Classification by specialty
| Hepato-biliary-pancreatic medicine | Pneumology | Infectious disease |
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The study aim to examine the mortality rate and clinical course, and the course after drug administration of COVID-19 in patients with liver disease, cirrhosis, liver cancer, biliary-pancreatic disease, cholangiocarcinoma, and pancreatic cancer.
Basic objectives2
Others
Basic objectives -Others
The study aim to examine the clinical course of COVID-19 patients with Hepatology-biliary pancreatic disease.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
mortality rate
Key secondary outcomes
1.Rate of patients with severe pneumonia
(Requirements of oxygen-support, invasive mechanical ventilation, hospitalization, entering intensive care unit)
2. Time to SARS-CoV-2 RT-PCR negativity
3. Duration of hospitalization
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Control group: COVID-19 patients without underlying diseases such as liver disease, cirrhosis, liver cancer, biliary-pancreatic disease, bile duct cancer, and pancreatic cancer
(2) Hepatobiliary-pancreatic disease group: COVID-19 patients with liver disease, cirrhosis, liver cancer, biliary-pancreatic disease, cholangiocarcinoma, pancreatic cancer
Key exclusion criteria
The following cases willn be excluded from both the control group and the hepatobiliary-pancreatic disease group
(1) If the patient requests that they do not wish to cooperate to this study
(2) HIV patients
(3) Patients with severe other organ failure
(4) Patients with advanced cancer of other organs
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Nobuhiro |
| Middle name | |
| Last name | Nakamoto |
Organization
Keio University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
160-8582
Address
35 Shinanomachi Shinjuku-ku, Tokyo
TEL
+81-3-3353-1211
nobuhiro@z2.keio.jp
Public contact
Name of contact person
| 1st name | Nobuhito |
| Middle name | |
| Last name | Taniki |
Organization
Keio University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
160-8582
Address
35 Shinanomachi Shinjuku-ku, Tokyo
TEL
+81-3-3353-1211
Homepage URL
http://www.keio-med.jp/gastro/
nobuhitotaniki@keio.jp
Sponsor or person
Institute
Keio University School of Medicine, Division of Gastroenterology and Hepatology, Department of Internal Medicine
Institute
Department
Personal name
Funding Source
Organization
Keio University School of Medicine, Division of Gastroenterology and Hepatology, Department of Internal Medicine
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
Keio University, School of Medicine
Address
35 Shinanomachi Shinjuku-ku, Tokyo
Tel
+81-3-3353-1211
med-rinri-jimu@adst.keio.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 | 04 | Month | 17 | 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 | 04 | Month | 17 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 17 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 17 | Day |
Last follow-up date
| 2026 | 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 | 04 | Month | 17 | Day |
Last modified on
| 2023 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045820
