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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000045149
Receipt No. R000051557
Scientific Title An Etiological and Observational study of Interstitial lung abnormalities (ILAs) including progressive fibrosing phenotype interstitial lung diseases in a large population of general medical examination (Kumamoto ILA study)
Date of disclosure of the study information 2021/12/01
Last modified on 2021/08/13

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Basic information
Public title An Etiological and Observational study of Interstitial lung
abnormalities (ILAs) in a large population of general medical examination (Kumamoto ILA study)
Acronym An Etiological and Observational study of Interstitial lung
abnormalities (ILAs) in a large population of general medical examination in Kumamoto
Scientific Title An Etiological and Observational study of Interstitial lung
abnormalities (ILAs) including progressive fibrosing phenotype interstitial lung diseases in a large population of general medical examination (Kumamoto ILA study)
Scientific Title:Acronym Kumamoto ILA study (KILA study)
Region
Japan

Condition
Condition Progressive fibrosing interstitial lung diseases including
idiopathic pulmonary fibrosis
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the natural course of progression and progression after the treatment initiation through screening at the pre-onset of progressive fibrous interstitial lung disease (PF-ILDs), including IPF among general medical examiners, and databases of ILA cases.
Basic objectives2 Others
Basic objectives -Others Annual frequency of cases diagnosed with PF-ILDs in
Interstitial Lung Abnormality (ILA) cases by high resolution CT images in general medical examinees.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Annual frequency of cases diagnosed with PF-ILDs in
Interstitial Lung Abnormality (ILA) cases by high resolution CT images in general medical examinees.
Key secondary outcomes 1) Frequency of ILA cases in all general medical
examinations.
2) Annual frequency of cases diagnosed with IPF in
cases of ILA.
3) Frequency of chronic hypersensitivity pneumonia and
interstitial pneumonia associated with collagen
disease in patients diagnosed with PF-ILD.

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 Patients who have a finding suggestive of interstitial pneumonia at the JRCS Health Management Center (approximately 30,000 people per year in general medical examination), Center for Preventive Medicine at the Saiseikai Kumamoto Hospital (approximately 30,000 people per year in general medical examination), and other medical facilities, and ILA is observed in HRCT findings by thorough examination at Kumamoto University Hospital, JRCS, and Saiseikai Kumamoto Hospital.
According to Reference 3), the diagnostic criteria for ILA are as follows: Abnormal shadows in the lung parenchyma such as reticular shadows and ground-glass opacity not due to gravity on the dorsal side of bilateral lower lobes, whose extent accounts for 5% or more of the lung field area.
Key exclusion criteria 1) Patients who are confirmed to refuse to participate in
the study after receiving an explanation of the
contents released for opt-out.
2) Patients with interstitial pneumonia occurring in an
acute or subacute course with no underlying
confirmed or presumed chronic course.
3) Patients who are difficult to be followed up regularly
due to circumstances such as residential areas.
4) Patients considered inappropriate for the study by the attending physician at the time of HRCT examination.
E.g.) In case it is difficult to appropriately perform or
evaluate the pulmonary function test or 6-minute
walk test In case understanding of the disease
status is not obtained.
5) Patients who are enrolled in interventional studies,
such as clinical trial, for which participation in other
observational studies has not been allowed.
However, in the case of observational study, it is
acceptable.
Target sample size 1500

Research contact person
Name of lead principal investigator
1st name Takuro
Middle name
Last name Sakagami
Organization Kumamoto University Medical Sciences
Division name Department of Respiratory Medicine
Zip code 861-4101
Address 1-1-1 Honjo, Chuoh-Ku, Kumamoto City, Japan
TEL 096-373-5012
Email stakuro@kumamoto-u.ac.jp

Public contact
Name of contact person
1st name Hidenori
Middle name
Last name Ichiyasu
Organization Kumamoto University Medical Sciences
Division name Department of Respiratory Medicine
Zip code 861-4101
Address 1-1-1 Honjo, Chuoh-Ku, Kumamoto City, Japan
TEL 096-373-5012
Homepage URL
Email ichiyasu@kumamoto-u.ac.jp

Sponsor
Institute Department of Respiratory Medicine
Kumamoto University Medical Sciences
Institute
Department

Funding Source
Organization Boehringer Ingelheim
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kumamoto University Medical Sciences Department of Respiratory Medicine
Address 1-1-1 Honjo, Chuoh-Ku, Kumamoto City, Japan
Tel 096-373-5012
Email ichiyasu@kumamoto-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 熊本大学病院呼吸器内科
熊本赤十字病院呼吸器内科、熊本赤十字病院健康管理センター
済生会熊本病院呼吸器内科、済生会熊本病院予防医療センター その他の熊本県下の健診医療機関

Other administrative information
Date of disclosure of the study information
2021 Year 12 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
2021 Year 08 Month 31 Day
Date of IRB
2021 Year 09 Month 30 Day
Anticipated trial start date
2022 Year 03 Month 15 Day
Last follow-up date
2029 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information 1)Initial evaluation
Age, sex, height, body weight, smoking history, history of
exposure to dust, comorbidities/medical history, family
history of interstitial pneumonia,
history of use of feather futons, history of exposure to
birds, living environment, collagen disease state, dyspnea sensitivity (modified MRC scale),
blood biochemistry, blood sampling for serum markers (KL-6, SP-D), blood sampling for autoantibody screening,
arterial blood gas, chest X-ray, HRCT *, pulmonary function test, 6 minute walk test distance,
confirmation degree of IPF (confidential, prospective high confidence, provisional low confidence, unclassifiable)
with or without lung cancer
HRCT pattern
2)At regular follow-up (every 6 months)
Presence of collagen disease symptoms, dyspnea
sensitivity (modified MRC scale) etc.
3) At the time of diagnosis of exacerbation (at the time of
introduction of treatment)
If the physician judges it necessary to introduce
a therapeutic drug including an antifibrotic drug based on
the guidelines.
Presence or absence of collagen disease symptoms, dyspnea sensitivity (modified MRC) etc.
After treatment introduction
The test items and frequency of administration that are
medically necessary will be left to the discretion of the
physician in charge, but the following items to be collected will continue to be evaluated every 4 -6 months.
4) Outcome, date of last observation, cause of death
Outcome
If the follow-up is terminated other than the end of the study observation period (moving, death, etc.), the date of the final observation and the cause of death will be recorded in the case of death.


Management information
Registered date
2021 Year 08 Month 13 Day
Last modified on
2021 Year 08 Month 13 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051557

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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