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
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
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
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
