UMIN-CTR Clinical Trial

Public title

An Observational Cohort Study of Interstitial Lung Abnormalities (ILAs) in a Large Japanese Health Screening Population (Kumamoto ILA study in Japan: KILA-J)

Acronym

An Observational Cohort Study of Interstitial Lung Abnormalities (ILAs) in a Large Japanese Health Screening Population (Kumamoto ILA study in Japan: KILA-J)

Scientific Title

An Observational Cohort Study of Interstitial Lung Abnormalities (ILAs) in a Large Japanese Health Screening Population (Kumamoto ILA study in Japan: KILA-J)

Scientific Title:Acronym

Kumamoto ILA study in Japan (KILA-J)

Region

Japan

Condition

Progressive fibrosing interstitial lung diseases including
idiopathic pulmonary fibrosis

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To clarify the natural course of progression and progression after the treatment initiation through screening at the pre-onset of IPF and progressive pulmonary fibrosis (PPF) among general medical examiners, and databases of ILA cases.

Basic objectives2

Others

Basic objectives -Others

Annual frequency of cases diagnosed with IPF and PPF 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

Primary outcomes

Annual frequency of cases diagnosed with IPF and PPF 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) Frequency of chronic hypersensitivity pneumonia and
interstitial pneumonia associated with collagen
disease in patients diagnosed with PPF.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Department of Respiratory Medicine
Kumamoto University Medical Sciences

Institute

Department

Personal name

Organization

Boehringer Ingelheim

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Date of disclosure of the study information

2021

Year

12

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Open public recruiting

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

06

Month

20

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 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 quantitative HRCT (AIQCT)
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.

The protocol is published in BMC Pulm Med 2023;Jun8;23(1):199

Registered date

2021

Year

08

Month

13

Day

Last modified on

2023

Year

08

Month

15

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051557