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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027844
Receipt No. R000031899
Scientific Title Prospective observational study of acute exacerbation in interstitial lung diseases for new diagnostic criteria
Date of disclosure of the study information 2017/07/01
Last modified on 2019/02/11

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Basic information
Public title Prospective observational study of acute exacerbation in interstitial lung diseases for new diagnostic criteria
Acronym Prospective observational study of acute exacerbation in interstitial lung diseases (AEILD Study)
Scientific Title Prospective observational study of acute exacerbation in interstitial lung diseases for new diagnostic criteria
Scientific Title:Acronym Prospective observational study of acute exacerbation in interstitial lung diseases (AEILD Study)
Region
Japan

Condition
Condition acute deterioration of interstitial lung diseases
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the relationship between prognosis and clinical factors in interstitial lung diseases after the deterioration of dyspnea with new pulmonary shadows
Basic objectives2 Others
Basic objectives -Others To make new diagnostic criteria of acute exacerbation of interstitial lung diseases
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Clinical factors to determine 3-month survival of acute deterioration in interstitial lung diseases
Key secondary outcomes 1)Clinical factors to determine 1-year survival of acute deterioration in interstitial lung diseases
2)Change of clinical parameters after acute deterioration of ILDs
3)Therapy
4)Cause of death
5)Adverse events
6)Efficacy of present diagnostic criteria of acute exacerbation
7)Comparison of present diagnostic criterion of acute exacerbation
8)To make a new diagnostic criteria of acute exacerbation of ILDs

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) idiopathic interstitial pneumonias (IIPs) and interstitial lung diseases (ILDs) other than IIPs including chronic hypersensitivity pneumonia, collagen vascular diseases-ILDs and asbestosis
2) Cases that deteriorated with deterioration of dyspnea and newly developed pulmonary shadows.
Key exclusion criteria 1) Survival is supposed to be less than 3 months due to complications of ILDs
2) Cases that researchers have determined to be improper for inclusion
Target sample size 800

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toru Arai
Organization NHO Kinki-Chuo Chest Medical Center
Division name Clinical Research Center
Zip code
Address 1180 Nagasone-Cho, Kita-Ku, Sakai, Osaka, Japan
TEL 072-252-3021
Email arai.toru.cp@mail.hosp.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuki Matsui, Chikatoshi Sugimoto
Organization NHO Kinki-Chuo Chest Medical Center
Division name Clinical Research Center
Zip code
Address 1180 Nagasone-Cho, Kita-Ku, Sakai, Osaka, Japan
TEL 072-252-3021
Homepage URL
Email matsui.yuki.yx@mail.hosp.go.jp

Sponsor
Institute National Hospital Organization Kinki-Chuo Chest Medical Center
Institute
Department

Funding Source
Organization National Hospital Organization
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 YES
Study ID_1 H28-NHO(Kokyu)-02
Org. issuing International ID_1 National Hospital Organization
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 07 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
2016 Year 12 Month 02 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 09 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Birth month, gender, past history, complications, smoking status, height, weight, physical examination, radiological findings, laboratory findings, therapy, clinical course, outcome, last follow-up date

Management information
Registered date
2017 Year 06 Month 20 Day
Last modified on
2019 Year 02 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031899

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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