UMIN-CTR Clinical Trial

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	2022 Year 06 Month 30 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	2022 Year 03 Month 09 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000006591