UMIN-CTR Clinical Trial

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
Email	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
Email	hirofumisei@gmail.com

Sponsor
Institute	Ehime University, School of Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048976

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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