UMIN-CTR Clinical Trial

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
Last 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
1st 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