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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000019744
Receipt No. R000022799
Scientific Title Exploring nucleic acids and specific proteins for diffuse lung diseases
Date of disclosure of the study information 2015/11/11
Last modified on 2018/02/22

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Basic information
Public title Exploring nucleic acids and specific proteins for diffuse lung diseases
Acronym Exploring nucleic acids and specific proteins for diffuse lung diseases
Scientific Title Exploring nucleic acids and specific proteins for diffuse lung diseases
Scientific Title:Acronym Exploring nucleic acids and specific proteins for diffuse lung diseases
Region
Japan

Condition
Condition Diffuse lung disease
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Exploring nucleic acids and specific proteins in patients with diffuse lung diseases
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Identification of nucleic acids and specific proteins in patients with diffuse lung diseases
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

Not applicable
Gender Male and Female
Key inclusion criteria 1: Patients with diffuse lung diseases (including suspected cases) who visited our hospital
2: Patients (or their legal representatives) who provided written informed consent
3: Aged over 20 years old
4: Both genders
5: Both inpatients and outpatients
Key exclusion criteria 1. Considered as inadequate by the investigator
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Kido
Organization University of Occupational and Environmental Health, Japan
Division name Department of Respiratory Medicine, School of Medicine
Zip code
Address 1-1 Iseigaoka Yahata-nishiku, Kitakyushu city Fukuoka 807-8555 JAPAN
TEL 093-691-7453
Email kokyukiresearch@mbox.med.uoeh-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tetsuya Hanaka
Organization University of Occupational and Environmental Health, Japan
Division name Department of Respiratory Medicine, School of Medicine
Zip code
Address 1-1 Iseigaoka Yahata-nishiku, Kitakyushu city Fukuoka 807-8555 JAPAN
TEL 093-691-7453
Homepage URL
Email kokyukiresearch@mbox.med.uoeh-u.ac.jp

Sponsor
Institute University of Occupational and Environmental Health, Japan
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2015 Year 11 Month 11 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
2015 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This study is prospective cohot study.The patients which admitte our or reffered hospital from Oct 1st, 2015 to Sep, 2018 and are equal with the criteria will be enrolled.

Management information
Registered date
2015 Year 11 Month 11 Day
Last modified on
2018 Year 02 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022799

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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