UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000005566
Receipt No. R000006591
Scientific Title A prospective multicenter clinical study on clinical course and prognosis of idiopathic pulmonary fibrosis
Date of disclosure of the study information 2011/05/07
Last modified on 2020/05/13

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title A prospective multicenter clinical study on clinical course and prognosis of idiopathic pulmonary fibrosis
Acronym A prospective multicenter study on clinical course and prognosis of IPF
Scientific Title A prospective multicenter clinical study on clinical course and prognosis of idiopathic pulmonary fibrosis
Scientific Title:Acronym A prospective multicenter study on clinical course and prognosis of IPF
Region
Japan

Condition
Condition Idiopathic pulmonary fibrosis
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose is to examine survival time and the progression-free survival time of IPF.
Basic objectives2 Others
Basic objectives -Others Survival study
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes 1) survival time
2) progression-free survival time
3) onset of acute exacerbation of IPF
4) onset of malignancies including primary lung cancer
Key secondary outcomes 1) changes in pulmonary function test
2) PaO2 at rest and desaturation during 6-min walking test
3) changes of SP-D and KL-6 in sera
4) changes of symptoms

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) The patient who showed an agreement of the participation to the study in a document by free will
2) Sex ; irrespective
3) Age ; 20 and over
4) In-/outpatient ; irrespective
5) The patient who was diagnosed as IPF according to the 4th version of the guideline of clinical diagnostic criteria for idiopathic interstitial pneumonia in Japan and who was authorized by Ministry of Health, Labour and Welfare specific disease
6) The patient who meets the 4th version of the guideline after the authorization
Key exclusion criteria 1) The patient who has the evident cause of interstitial pneumonia such as collagen-vascular diseases, drug, environmental exposure, hypersensitivity pneumonitis, and infection.
2) The patient whom it was judged to be inadequate with HRCT.
3) The patient who has a malignant tumor or who had it with the past.
4) The patient who was judged to be inappropriate as an object of this study due to severe complications.
5) The patient who was judged to be inappropriate as an object of this study by a medical attendant.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name Hiroki
Middle name
Last name Takahashi
Organization Sapporo Medical University School of Medicine
Division name Department of Respiratory Medicine and Allergology
Zip code 060-8543
Address West 16 South 1, Chuo-ku, Sapporo, 060-8543, JAPAN
TEL 011-611-2111
Email htaka@sapmed.ac.jp

Public contact
Name of contact person
1st name Masanori
Middle name
Last name Shiratori
Organization Sapporo Medical University School of Medicine
Division name Department of Respiratory Medicine and Allergology
Zip code 060-8543
Address West 16 South 1, Chuo-ku, Sapporo, 060-8543, JAPAN
TEL 011-611-2111
Homepage URL
Email hokkaido-ild@sapmed.ac.jp

Sponsor
Institute Hokkaido Study Group of Interstitial Lung Diseases
Institute
Department

Funding Source
Organization SHIONOGI & CO., LTD.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Sapporo Medical University Hospital
Address West 16 South 1, Chuo-ku, Sapporo, 060-8543, Japan
Tel 011-611-2111
Email htaka@sapmed.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 JR札幌病院(北海道)、KKR札幌医療センター(北海道)、NTT東日本札幌病院(北海道)、旭川医科大学病院(北海道)、旭川赤十字病院(北海道)、旭川厚生病院(北海道)、岩見沢市立総合病院(北海道)、王子総合病院(北海道)、小樽協会病院(北海道)、帯広協会病院(北海道)、帯広厚生病院(北海道)、おびひろ呼吸器科内科病院(北海道)、国立病院機構旭川医療センター(北海道)、国立病院機構函館病院(北海道)、国立病院機構北海道医療センター(北海道)、札幌医科大学附属病院(北海道)、札幌厚生病院(北海道)、札幌南三条病院(北海道)、市立旭川病院(北海道)、市立釧路総合病院(北海道)、市立札幌病院(北海道)、市立千歳市民病院(北海道)、市立函館病院(北海道)、市立室蘭総合病院(北海道)、製鉄記念室蘭病院(北海道)、砂川市立病院(北海道)、手稲渓仁会病院(北海道)、天使病院(北海道)、苫小牧市立病院(北海道)、函館五稜郭病院(北海道)、北海道社会保険病院(北海道)、北海道大学病院(北海道)、北海道中央労災病院(北海道)、北海道立苫小牧病院(北海道)、牧田病院(北海道)

Other administrative information
Date of disclosure of the study information
2011 Year 05 Month 07 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 135
Results
Results date posted
Results Delayed
Delay expected
Results Delay Reason It takes time to analyze the data
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 No longer recruiting
Date of protocol fixation
2010 Year 06 Month 01 Day
Date of IRB
2010 Year 05 Month 19 Day
Anticipated trial start date
2010 Year 06 Month 01 Day
Last follow-up date
2016 Year 09 Month 30 Day
Date of closure to data entry
2017 Year 03 Month 31 Day
Date trial data considered complete
2018 Year 05 Month 31 Day
Date analysis concluded
2020 Year 12 Month 31 Day

Other
Other related information Although influence of vital capacity (VC) is suggested as a factor to have an influence on the prognosis of IPF, we will perform the examination about other factors such as disease severity and serum markers in addition.

Management information
Registered date
2011 Year 05 Month 07 Day
Last modified on
2020 Year 05 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006591

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.