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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032926
Receipt No. R000037537
Official scientific title of the study Analysis for autoimmune components and the disease activity of interstitial pneumonia patients
Date of disclosure of the study information 2018/06/08
Last modified on 2018/06/08

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Basic information
Official scientific title of the study Analysis for autoimmune components and the disease activity of interstitial pneumonia patients
Title of the study (Brief title) Interstitial pneumonia associated with autoimmune
Region
Japan

Condition
Condition patients with interstitial pneumonia
Classification by specialty
Medicine in general Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 positive ratio of autoantibodies
Basic objectives2 Others
Basic objectives -Others Positive ratio of autoantibodies and the survival rate of the patients
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes positive ratio of autoantibodies
Key secondary outcomes

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
20 years-old <
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria patients with interstititial shadow
COPD
Asthma
Key exclusion criteria <20 years old
Target sample size 900

Research contact person
Name of lead principal investigator Yoshiki Ishii
Organization Dokkyo Medical University School of Medicine
Division name Department of Pulmonary Medicine and Clinical Immunology
Address 880 Kitakobayashi, Mibu, Tochigi 321-0293, Japan
TEL 0282861111
Email ishiiysk@dokkyomed.ac.jp

Public contact
Name of contact person Yasuo Shimizu
Organization Dokkyo Medical University School of Medicine
Division name Department of Pulmonary Medicine and Clinical Immunology
Address 880 Kitakobayashi, Mibu, Tochigi 321-0293, Japan
TEL 0282861111
Homepage URL
Email yasuo-s@dokkyomed.ac.jp

Sponsor
Institute Dokkyo Medical University School of Medicine
Institute
Department

Funding Source
Organization Dokkyo Medical University School of Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

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
2018 Year 06 Month 08 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 04 Month 18 Day
Anticipated trial start date
2018 Year 05 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information none

Management information
Registered date
2018 Year 06 Month 08 Day
Last modified on
2018 Year 06 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037537

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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