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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000042904
Receipt No. 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

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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
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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