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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000040208
Receipt No. 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 2020/10/21

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

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 Enrolling by invitation
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
2020 Year 10 Month 21 Day


Link to view the page
URL(English) https://upload.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


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