UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044751 |
|---|---|
| Receipt number | R000051107 |
| Scientific Title | Evaluation of quality of life of patients with food allergy and their guardians using a questionnaire |
| Date of disclosure of the study information | 2021/07/05 |
| Last modified on | 2021/07/03 22:59:42 |
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Basic information
Public title
Evaluation of quality of life of patients with food allergy and their guardians using a questionnaire
Acronym
Evaluation of quality of life of patients with food allergy and their guardians
Scientific Title
Evaluation of quality of life of patients with food allergy and their guardians using a questionnaire
Scientific Title:Acronym
Evaluation of quality of life of patients with food allergy and their guardians
Region
| Japan |
Condition
Condition
food allergy
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Assessing the quality of life (QOL) of patients with food allergies and their guardians over time
Basic objectives2
Others
Basic objectives -Others
Assessing the clinical course and the patient parameters that impact QOL
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time course of changes in quality of life for patients and guardians
Key secondary outcomes
Relationship between clinical course of food allergy and QOL
Influence of the course of oral food challenge or oral immunotherapy on QOL
Correlation between immunological changes and the score of QOL
Relationship between patient's clinical profile and QOL
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
| 1 | months-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed by a physician with food allergy and their guardians
Key exclusion criteria
Decision of ineligibility by a physician
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Noriyuki |
| Middle name | |
| Last name | Yanagida |
Organization
National Hospital Organization Sagamihara National Hospital
Division name
Department of pediatrics
Zip code
252-0392
Address
18-1, Sakuradai, Minamiku, Sagamihara City, Kanagawa, Japan, 252-0392
TEL
042-742-8311
yana@foodallergy.jp
Public contact
Name of contact person
| 1st name | Yoko |
| Middle name | |
| Last name | Miura |
Organization
National Hospital Organization Sagamihara National Hospital
Division name
Department of pediatrics
Zip code
252-0392
Address
18-1, Sakuradai, Minamiku, Sagamihara City, Kanagawa, Japan, 252-0392
TEL
042-742-8311
Homepage URL
yoko6299@gmail.com
Sponsor or person
Institute
National Hospital Organization Sagamihara National Hospital
Institute
Department
Personal name
Funding Source
Organization
no funding
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
Sagamihara Hospital Ethics Committee of the National Hospital Organization
Address
18-1, Sakuradai, Minamiku, Sagamihara City, Kanagawa, Japan, 252-0392
Tel
042-742-8311
222-rinri@mail.hosp.go.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 | 07 | 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
| 2021 | Year | 05 | Month | 25 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 28 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 05 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Parents of patients with food allergies and patients aged 9 years and older receive a web-based or paper questionnaire at the time of consent and annually afterwards.
Management information
Registered date
| 2021 | Year | 07 | Month | 03 | Day |
Last modified on
| 2021 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051107
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
