UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005566
Receipt number 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 2022/03/09 10:16:23

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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 or person

Institute

Hokkaido Study Group of Interstitial Lung Diseases

Institute

Department

Personal name



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

Value
https://center6.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