UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042904 |
|---|---|
| Receipt number | R000048976 |
| Scientific Title | Evaluation of cases of sarcopenic dysphagia at our hospital and examination of treatment methods. |
| Date of disclosure of the study information | 2021/01/05 |
| Last modified on | 2021/01/05 10:50:31 |
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Basic information
Public title
Evaluation of cases of sarcopenic dysphagia at our hospital and examination of treatment methods.
Acronym
Evaluation of cases of sarcopenic dysphagia at our hospital and examination of treatment methods.
Scientific Title
Evaluation of cases of sarcopenic dysphagia at our hospital and examination of treatment methods.
Scientific Title:Acronym
Evaluation of cases of sarcopenic dysphagia at our hospital and examination of treatment methods.
Region
| Japan |
Condition
Condition
dysphagia
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To contribute to the development of diagnostic criteria and treatments for dysphagia by conducting multifaceted clinical studies on cases that meet the diagnostic criteria for dysphagia in sarcopenia and obtaining new findings such as prognostic risk factors.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Food intake level scale (FILS)
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Men and women over the age of 20
With or without medical history or complications
Key exclusion criteria
Cases with difficulty in measuring grip and body composition
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Hirofumi |
| Middle name | |
| Last name | Sei |
Organization
Ehime University, School of Medicine
Division name
Department of Otolaryngology
Zip code
791-0295
Address
Toon-city Shitsukawa, Ehime 91-0295, Japan
TEL
089-960-5366
hirofumisei@gmail.com
Public contact
Name of contact person
| 1st name | Hirofumi |
| Middle name | |
| Last name | Sei |
Organization
Ehime University, School of Medicine
Division name
Department of Otolaryngology
Zip code
791-0295
Address
Toon-city Shitsukawa, Ehime 91-0295, Japan
TEL
089-960-5366
Homepage URL
hirofumisei@gmail.com
Sponsor or person
Institute
Ehime University, School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ehime University, School of 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
Institutional Review Board,Ehime University Hospital
Address
Shitsukawa, Toon, Ehime
Tel
089-960-5172
rinri@m.ehime-u.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 | 01 | Month | 05 | 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 | 08 | Month | 25 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 25 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 25 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Ethic
1. Explanation to Subjects
･The clinical investigator sufficiently explains to subjects using the explanatory document approved by IRB in advance.
･Candidates for subject and observers are given sufficient time and rogatory opportunities to judge whether they approve or not.
･After confirming subjects' understanding of this study's content, we obtain their approval by their own volition.
2. Compensation for Health Damage
This study uses the information of subjects collected in daily medical care. Given no health damage to subjects due to these issues, compensation will be prepared.
3. Store of Records and Materials
We store the test result and approval documents obtained in this study on an electronic chart. They will be stored for five years held date of completion of this study or 3 years from the three of final publication of study results, whichever comes later, and will be finely cut so that personal information cannot be specified when discarded.
4. Treatment of Personal Information
The test data is analyzed statistically, with a conversion table and anonymization of patients' names ae principal inv namesestigator rigidly manages personal information, keeping it in a locker with a key. We pay careful attention to the subjects' information protection.
5. Provision of the Medical Treatment after the Study Termination
Additional medical treatment is not provided due to an observational study.
6. Handling of Study Results
The test results are explained to subjects, and the study results are disclosed promptly after this study by the protocol.
Management information
Registered date
| 2021 | Year | 01 | Month | 05 | Day |
Last modified on
| 2021 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048976
