UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046339 |
|---|---|
| Receipt number | R000052875 |
| Scientific Title | Examination of the natural course of F1 and RC-positive esophageal varices |
| Date of disclosure of the study information | 2021/12/10 |
| Last modified on | 2021/12/10 01:37:29 |
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Basic information
Public title
Examination of the natural course of F1 and RC-positive esophageal varices
Acronym
Examination of the natural course of F1 and RC-positive esophageal varices
Scientific Title
Examination of the natural course of F1 and RC-positive esophageal varices
Scientific Title:Acronym
Examination of the natural course of F1 and RC-positive esophageal varices
Region
| Japan |
Condition
Condition
esophageal varices
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
the natural course of F1 and RC-positive esophageal varices
Basic objectives2
Others
Basic objectives -Others
Significance of RC positive
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Factors related to bleeding and early bleeding
Key secondary outcomes
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
| 43 | years-old | <= |
Age-upper limit
| 82 | years-old | > |
Gender
Male and Female
Key inclusion criteria
F1 and RC positive
Key exclusion criteria
F1 and RC negative
Follow-up within half a year
Target sample size
76
Research contact person
Name of lead principal investigator
| 1st name | Kazunori |
| Middle name | |
| Last name | Nagashima |
Organization
Dokkyo Medical University School of Medicine
Division name
Department of Gastroenterology
Zip code
321-0293
Address
880, Kitakobayashi, Mibu, Shimotsuga, Tochigi, Japan
TEL
0282-86-1111
n-kazu@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Kazunori |
| Middle name | |
| Last name | Nagashima |
Organization
Dokkyo Medical University School of Medicine
Division name
Department of Gastroenterology
Zip code
321-0293
Address
880, Kitakobayashi, Mibu, Shimotsuga, Tochigi, Japan
TEL
0282-86-1111
Homepage URL
n-kazu@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University School of Medicine
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
Dokkyo Medical University School of Medicine
Address
880, Kitakobayashi, Mibu, Shimotsuga, Tochigi, Japan
Tel
0282-86-1111
n-kazu@dokkyomed.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
| 2021 | Year | 12 | Month | 10 | 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
76
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
Completed
Date of protocol fixation
| 2020 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 12 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 30 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2021 | Year | 12 | Month | 10 | Day |
Last modified on
| 2021 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052875
| Research Plan | |
|---|---|
| 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 |
