UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036514 |
|---|---|
| Receipt number | 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 14:00:15 |
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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
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
transoral@ent.kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
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
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
Value
https://center6.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 |
