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

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 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

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

Value
https://center6.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