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 | 2024/05/07 09:35:51 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
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
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
Completed
Date of protocol fixation
| 2016 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 11 | Day |
Last follow-up date
| 2019 | Year | 05 | Month | 15 | Day |
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
| 2024 | 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
