UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022232
Receipt number R000025597
Scientific Title Prospective observational study to predict sensitive marker after administration of nintedanib in patients with idiopathic pulmonary fibrosis
Date of disclosure of the study information 2016/05/09
Last modified on 2016/05/07 00:10:56

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Basic information

Public title

Prospective observational study to predict sensitive marker after administration of nintedanib in patients with idiopathic pulmonary fibrosis

Acronym

Exploratory investigation in idiopathic pulmonary fibrosis

Scientific Title

Prospective observational study to predict sensitive marker after administration of nintedanib in patients with idiopathic pulmonary fibrosis

Scientific Title:Acronym

Exploratory investigation in idiopathic pulmonary fibrosis

Region

Japan


Condition

Condition

Pulmonary fibrosis

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Nintedanib is active for treatment of previously treated NSCLC. However, there have been no established biomarker to predict the efficcy and outcome after administration of Nintedanib. In this study, we explored the promising markers as a prediction of Nintedanib using blood samples.

Basic objectives2

Others

Basic objectives -Others

Potential of monitoring Nintedanib by any biomarkers

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

To explore the pretictive biomarkers after and before Nintedanib using blood samples.

Key secondary outcomes



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

Pathologically or radiologically diagnozed idiopathic pulmonary fibrosis

PS of 0-2

Adequate organ function

expected more than 3-month survivors

Candidate for administration of nivolumab

Key exclusion criteria

Judgement as exclusion by chief mdical physians

Acute crdac infarcton or angina pectoris

Candidate for lung transplntation

With malignant disease

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yasuhiko Koga

Organization

Gunma University Hospital

Division name

Department of Respiratory medicine

Zip code


Address

3-39-22, Showa-machi, Maebashi, Gunma, 371-8511, Japan.

TEL

027-220-8136

Email

kkaira1970@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kyoichi Kaira

Organization

Gunma University Graduate of Medicine

Division name

Department of Oncology Clinical Development

Zip code


Address

3-39-22, Showa-machi, Maebashi, Gunma, 371-8511, Japan

TEL

027-220-8122

Homepage URL


Email

kkaira1970@yhoo.co.jp


Sponsor or person

Institute

Gunma University

Institute

Department

Personal name



Funding Source

Organization

Gunma University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2016 Year 05 Month 09 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

Open public recruiting

Date of protocol fixation

2016 Year 05 Month 01 Day

Date of IRB


Anticipated trial start date

2016 Year 05 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Study design; Cohort study

Registration: May. 2016 to April. 2019, compatible with inclusion criteria



Using blood sample, any biomarkers before and after Nintetanib administration and measured. Several points after 1,3,6 and 12months are assessed to find an appropriate point after Nitetanib. We explored the relationship between the efficacy of nivolumab and the expression level of several markers.


Management information

Registered date

2016 Year 05 Month 07 Day

Last modified on

2016 Year 05 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025597


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name