UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021503 |
|---|---|
| Receipt number | R000024798 |
| Scientific Title | Identification of biomarkers for diagnosis and prognosis in the patients with obstructive sleep apnea |
| Date of disclosure of the study information | 2016/03/16 |
| Last modified on | 2018/07/18 11:31:50 |
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Basic information
Public title
Identification of biomarkers for diagnosis and prognosis in the patients with obstructive sleep apnea
Acronym
Identification of biomarkers for diagnosis and prognosis in the patients with obstructive sleep apnea
Scientific Title
Identification of biomarkers for diagnosis and prognosis in the patients with obstructive sleep apnea
Scientific Title:Acronym
Identification of biomarkers for diagnosis and prognosis in the patients with obstructive sleep apnea
Region
| Japan |
Condition
Condition
obstructive sleep apnea
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the useful biomarkers to diagnosis and prognosis prediction in the patients with obstructive sleep apnea
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
microRNA in plasma
Key secondary outcomes
protein in plasma
polysomnography
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
The patients consent to this investigation
Key exclusion criteria
The patients found to be inadequate by attending physicians for this investigation
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Norihisa Ito |
Organization
Osaka university graduate School of medicine
Division name
The department of geriatric and general medicine
Zip code
Address
2-2, Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-3852
itoh@geriat.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Norihisa Ito |
Organization
Osaka university graduate School of medicine
Division name
The department of geriatric and general medicine
Zip code
Address
2-2, Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-3852
Homepage URL
itoh@geriat.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka university graduate School of medicine
The department of geriatric and general medicine
Institute
Department
Personal name
Funding Source
Organization
Osaka university graduate School of medicine
The department of geriatric and general medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 03 | Month | 16 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 03 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 16 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
cohort study
The objective is the patients consent to this investigation.
Study duration is from Mar/16/2016 to Dec/31/2021.
Investigation to miRNA in plasma, protein in plasma and polysomnography etc.
Management information
Registered date
| 2016 | Year | 03 | Month | 16 | Day |
Last modified on
| 2018 | Year | 07 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024798
