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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name