UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048975 |
|---|---|
| Receipt number | R000055797 |
| Scientific Title | Observational Study on Novel Biomarkers for Prediction of Pneumonia in the Elderly |
| Date of disclosure of the study information | 2022/09/22 |
| Last modified on | 2024/03/22 09:06:42 |
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Basic information
Public title
Research on the useful test for predicting the pneumonia in the Elderly
Acronym
Research for prediction of the Elderly pneumonia
Scientific Title
Observational Study on Novel Biomarkers for Prediction of Pneumonia in the Elderly
Scientific Title:Acronym
Observational Study for Prediction of Pneumonia in the Elderly
Region
| Japan |
Condition
Condition
Pneumonia
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Exploratory study of predictive markers for the development of pneumonia in the elderly
Basic objectives2
Others
Basic objectives -Others
Purpose of biomarker evaluation
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Elderly with or without pneumonia within 24 months of incorporation
Key secondary outcomes
Prognosis of Pneumonia in the Elderly
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Currently attending day-care rehabilitation at a joint research institute
2. Those who need support 1 and 2, and those who need nursing care 1
3. Patients who have received a thorough explanation of their participation in this study, and who have given their (or their surrogate's) free and voluntary consent based on a thorough understanding of the subject.
Key exclusion criteria
1. Those who have developed pneumonia at the time of obtaining consent
2. Those who do not give consent for blood or urine collection
3. Those who have decided to move to a new location during the approximately 2-year observation period.
4. Those with malignant diseases, whose prognosis is considered to be within about 2 years.
5. Other patients who are deemed inappropriate as research subjects by the investigator or others.
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Iwanaga |
Organization
Nagasaki University Hospital
Division name
Department of Respiratory Medicine
Zip code
8528501
Address
Sakamoto 1-7-1, Nagasaki City
TEL
095-819-7273
niwanaga@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Iwanaga |
Organization
Nagasaki University Hospital
Division name
Department of Respiratory Medicine
Zip code
8528501
Address
Sakamoto 1-7-1, Nagasaki City
TEL
095-819-7273
Homepage URL
niwanaga@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Hospital
Department of Respiratory Medicine
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University Hospital
Department of Respiratory Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Center, Nagasaki University Hospital
Address
Sakamoto 1-7-1, Nagasaki City
Tel
095-819-7726
rinshou7726@umin.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
| 2022 | Year | 09 | Month | 22 | 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
| 2022 | Year | 09 | Month | 22 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 22 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational and exploratory studies
Management information
Registered date
| 2022 | Year | 09 | Month | 20 | Day |
Last modified on
| 2024 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055797
