UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040208
Receipt number R000045130
Scientific Title Study on epidemiology and biomarkers of diffuse lung diseases
Date of disclosure of the study information 2020/06/01
Last modified on 2022/04/23 21:05:31

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Basic information

Public title

Study on epidemiology and biomarkers of diffuse lung diseases

Acronym

Study on epidemiology and biomarkers of diffuse lung diseases

Scientific Title

Study on epidemiology and biomarkers of diffuse lung diseases

Scientific Title:Acronym

Study on epidemiology and biomarkers of diffuse lung diseases

Region

Japan


Condition

Condition

diffuse lung diseases

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

Elucidating the natural history and prognostic factors of diffuse lung diseases by conducting long-term follow up and accumulation of clinical and genetic information of patients with diffuse lung dieases.

Basic objectives2

Others

Basic objectives -Others

Elucidation of epidemiology and genetic predisposition

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Prevalence and prognosis of diffuse lung diseases

Key secondary outcomes

Susceptibility genes of diffuse lung diseases


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

1) Idiopathic interstitial pneumonia and other diffuse lung diseases diagnosed based on international guidelines
2) Diffuse pulmonary disease patients whose blood, lung tissue and bronchoalveolar lavage fluid samples had been obtained with consent in previous studies
3) Unrelated patients with diffuse lung disease (parents, children, siblings)
4) Unrelated persons in the Nagahama cohort

Key exclusion criteria

1) Patients who do not give consent to participate in the study or who refuse to participate by opt-out
2) Patients judged to be inappropriate as participants by the judgment of researchers.

Target sample size

1000


Research contact person

Name of lead principal investigator

1st name Tomohiro
Middle name
Last name Handa

Organization

Graduate school of medicine, Kyoto university

Division name

Department of advanced medicine for respiratory failure

Zip code

6068507

Address

54 Kawaharacho Shogoin Sakyo-ku, Kyoto, Japan

TEL

075-366-7689

Email

hanta@kuhp.kyoto-u.ac.jp


Public contact

Name of contact person

1st name Tomohiro
Middle name
Last name Handa

Organization

Graduate school of medicine, Kyoto university

Division name

Department of advanced medicine for respiratory failure

Zip code

6068507

Address

54 Kawaharacho Shogoin Sakyo-ku, Kyoto, Japan

TEL

075-366-7689

Homepage URL


Email

hanta@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

Department of advanced medicine for respiratory failure,Graduate school of medicine, Kyoto university

Institute

Department

Personal name



Funding Source

Organization

Japan Agency for Medical Research and Development (AMED) Research Fund for Practical Research Project for Intractable Diseases / MHLW Research Fund for Intractable Diseases Policy Research Program

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kyoto university graduate school and faculty of medicine Ethics comittee

Address

Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN

Tel

075-753-4680

Email

ethcom@kuhp.kyoto-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



Other administrative information

Date of disclosure of the study information

2020 Year 06 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

Open public recruiting

Date of protocol fixation

2020 Year 01 Month 26 Day

Date of IRB

2020 Year 06 Month 03 Day

Anticipated trial start date

2020 Year 07 Month 01 Day

Last follow-up date

2025 Year 06 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

The following information will be tracked.
1) Genome information (peripheral blood telomere length, whole genome sequence)
2) Physical findings: Chest auscultation findings, presence / absence of finger clubbing etc.
3) Patient background (diagnosis, age, sex, height, weight, comorbidities, medical history, family history, smoking history, etc.)
4) Subjective symptoms (MRC dyspnea scale (ATS / ERS 2004), presence of dry cough and other symptoms
5) Blood test (blood count, coagulation (PT / APTT / Fibrinogen), biochemistry (TP / Alb / LDH / Ch-E / Cr / eGFR / BUN / UA / T-CHO / TG), serum immunological test (CRP), KL-6 / SP-D / BNP, etc.
6) Bronchoalveolar lavage fluid
7) Physiological tests(blood gas, respiratory function test, 6-minute walking test)8) Chest Images: Chest X-ray, chest CT
9) EQ-5D-5L survey
10) Presence or absence of acute exacerbation, lung transplantation, pneumothorax, death, etc.


Management information

Registered date

2020 Year 04 Month 21 Day

Last modified on

2022 Year 04 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045130


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name