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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036514
Receipt No. R000041601
Scientific Title Patient registry for pharyngeal/laryngeal/tracheal stenosis
Date of disclosure of the study information 2019/06/01
Last modified on 2019/04/15

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Basic information
Public title Patient registry for pharyngeal/laryngeal/tracheal stenosis
Acronym Patient registry for airway stenosis
Scientific Title Patient registry for pharyngeal/laryngeal/tracheal stenosis
Scientific Title:Acronym Patient registry for airway stenosis
Region
Japan

Condition
Condition Pharyngeal/laryngeal/tracheal stenosis
Classification by specialty
Chest surgery Pediatrics Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Accumulate patient's clinical information in pharyngeal/laryngeal/tracheal stenosis and elucidate natural history and prognostic factors
Basic objectives2 Others
Basic objectives -Others Multicenter joint registry research
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Stenosis (symptom, degree (site, length), treatments, prognosis, etc)
Key secondary outcomes Presence (or absence) of tracheostomy stoma
Eating Assesment Tool 10
Voice Handicap Index 10
EQ-5D-5L (Scale of quality of life)
Respiratory assessment scale
Nutrition assessment scale

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Diagnosed as pharyngeal/Laryngeal/tracheal stenosis
Provide written informed consent
Key exclusion criteria Be concluded not eligible to enter the study by a principle investigator or sub-investigator.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Koichi
Middle name
Last name Omori
Organization Graduate School of Medicine, Kyoto University
Division name Department of Otolaryngology-Head and Neck Surgery
Zip code 606-8507
Address 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, JAPAN
TEL +81-75-751-3346
Email omori@ent.kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name Yo
Middle name
Last name Kishimoto
Organization Graduate School of Medicine, Kyoto University
Division name Department of Otolaryngology-Head and Neck Surgery
Zip code 606-8507
Address 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, JAPAN
TEL +81-75-751-3346
Homepage URL
Email transoral@ent.kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Graduate School of Medicine, Kyoto University
Address 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, JAPAN
Tel +81-75-753-4680
Email ethcom@kuhp.kyoto-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
2019 Year 06 Month 01 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 Preinitiation
Date of protocol fixation
2019 Year 03 Month 31 Day
Date of IRB
Anticipated trial start date
2019 Year 06 Month 01 Day
Last follow-up date
2024 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Follow-up survey will be conducted annually after the initial registration

Management information
Registered date
2019 Year 04 Month 15 Day
Last modified on
2019 Year 04 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041601

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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