UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009322
Receipt number R000010949
Scientific Title A survey of prognosis for idiopathic pulmonary fibrosis who receive long term oxygen therapy.
Date of disclosure of the study information 2012/11/13
Last modified on 2019/05/21 18:22:13

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Basic information

Public title

A survey of prognosis for idiopathic pulmonary fibrosis who receive long term oxygen therapy.

Acronym

A survey of prognosis for IPF who receive LTOT.

Scientific Title

A survey of prognosis for idiopathic pulmonary fibrosis who receive long term oxygen therapy.

Scientific Title:Acronym

A survey of prognosis for IPF who receive LTOT.

Region

Japan


Condition

Condition

idiopathic pulmonary fibrosis

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the survival of patients with idiopathic pulmonary fibrosis (IPF) receiving long term oxygen therapy (LTOT).

Basic objectives2

Others

Basic objectives -Others

To grasp and analyze the current situation of the survival of patients with IPF receiving LTOT.

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

To investigate the survival of patients with idiopathic pulmonary fibrosis (IPF) receiving long term oxygen therapy (LTOT).

Key secondary outcomes

To evaluate prognostic factor of patients with IPF receiving LTOT.


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

IPF patients newly prescribed LTOT

Key exclusion criteria

None

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Kensuke
Middle name
Last name Kataoka

Organization

Tosei General Hospital

Division name

Department of Respiratory Medicine and Allergy

Zip code

4898642

Address

160 Nishioiwake-cho, Seto city, Aichi, Japan

TEL

0561-82-5101

Email

lung@tosei.or.jp


Public contact

Name of contact person

1st name Kensuke
Middle name
Last name Kataoka

Organization

Tosei General Hospital

Division name

Department of Respiratory Medicine and Allergy

Zip code

4898642

Address

160 Nishioiwake-cho, Seto city, Aichi, Japan

TEL

0561-82-5101

Homepage URL


Email

kataoka@tosei.or.jp


Sponsor or person

Institute

The Diffuse Lung Disease Group from the Ministry of Health,Labour and Welfare (Japan).

Institute

Department

Personal name



Funding Source

Organization

The Diffuse Lung Disease Group from the Ministry of Health,Labour and Welfare (Japan).

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Tosei General Hospital

Address

160 Nishioiwake-cho, Seto city, Aichi, Japan

Tel

0561-82-5101

Email

shomu@tosei.or.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



Other administrative information

Date of disclosure of the study information

2012 Year 11 Month 13 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

No longer recruiting

Date of protocol fixation

2012 Year 02 Month 01 Day

Date of IRB

2015 Year 01 Month 17 Day

Anticipated trial start date

2012 Year 11 Month 13 Day

Last follow-up date

2018 Year 11 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

No longer recruiting


Management information

Registered date

2012 Year 11 Month 12 Day

Last modified on

2019 Year 05 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010949


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name