UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039537 |
|---|---|
| Receipt number | R000045087 |
| Scientific Title | An observation study of perioperative nintedanib therapy in patients with non-small-cell lung cancer combined with idiopathic pulmonary fibrosis (IPF) |
| Date of disclosure of the study information | 2020/03/01 |
| Last modified on | 2020/08/20 14:45:13 |
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Basic information
Public title
An observation study of perioperative nintedanib therapy in patients with non-small-cell lung cancer combined with idiopathic pulmonary fibrosis (IPF)
Acronym
Nintedanib therapy in patients with NSCLC with IPF
Scientific Title
An observation study of perioperative nintedanib therapy in patients with non-small-cell lung cancer combined with idiopathic pulmonary fibrosis (IPF)
Scientific Title:Acronym
Nintedanib therapy in patients with NSCLC with IPF
Region
| Japan |
Condition
Condition
non-small-cell lung cancer combined with idiopathic pulmonary fibrosis (IPF)
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Safety
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety
Key secondary outcomes
Postoperative exacerbation-free time of IPF
2-year survival rate
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
Non-small-cell lung cancer combined with idiopathic pulmonary fibrosis (IPF)
Clinical stage I-IIIA
Patient who has operative indication
Key exclusion criteria
Past history of chest surgery
Alternative prior treatment for IPF
Past history of chemotherapy or radiation for chest
Administration of oxygen therapy
Infectious disease requiring treatment
Target sample size
23
Research contact person
Name of lead principal investigator
| 1st name | Hidetaka |
| Middle name | |
| Last name | Uramoto |
Organization
Kanazawa Medical University
Division name
Thoracic Surgery
Zip code
920-0293
Address
1-1 daigaku, Uchinada, Ishikawa Japan
TEL
0762862211
hidetaka@kanazawa-med.ac.jp
Public contact
Name of contact person
| 1st name | Nozomu |
| Middle name | |
| Last name | Motono |
Organization
Kanazawa Medical University
Division name
Thoracic Surgery
Zip code
920-0293
Address
1-1 daigaku, Uchinada, Ishikawa, Japan
TEL
0762862211
Homepage URL
motono@kanazawa-med.ac.jp
Sponsor or person
Institute
Kanazawa Medical University
Institute
Department
Personal name
Funding Source
Organization
Kanazawa Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Institutional Review Boards of Kanazawa Medical University
Address
1-1 daigaku, Uchinada, Ishikawa, Japan
Tel
0762188346
tiken@kanazawa-med.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 03 | Month | 01 | 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
1
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
Terminated
Date of protocol fixation
| 2020 | Year | 02 | Month | 04 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 02 | Day |
Last follow-up date
| 2020 | Year | 08 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation study
Management information
Registered date
| 2020 | Year | 02 | Month | 19 | Day |
Last modified on
| 2020 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045087
