UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018227 |
|---|---|
| Receipt number | R000021094 |
| Scientific Title | Multicenter nation-wide retrospective study in patients with idiopathic interstitial pneumonias associated with advanced primary lung cancer |
| Date of disclosure of the study information | 2015/09/01 |
| Last modified on | 2023/07/14 19:10:43 |
* 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
Multicenter nation-wide retrospective study in patients with idiopathic interstitial pneumonias associated with advanced primary lung cancer
Acronym
Treatment in patients with idiopathic interstitial pneumonias associated with advanced lung cancer
Scientific Title
Multicenter nation-wide retrospective study in patients with idiopathic interstitial pneumonias associated with advanced primary lung cancer
Scientific Title:Acronym
Treatment in patients with idiopathic interstitial pneumonias associated with advanced lung cancer
Region
| Japan |
Condition
Condition
idiopathic interstitial pneumonias associated with advanced stage primary lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aims of this study are to demonstrate the regimens of chemotherapy in which are most frequently available in the clinical setting and to confirm the safety and efficacy of these regimens, in addition, to identify the proportion who received chemotherapy or best supportive care as the first line treatment in patients with idiopathic interstitial pneumonia assciated with advenced stage primary lung cancer.
Basic objectives2
Others
Basic objectives -Others
One of the issues to treat these patients, acute exacerbation of interstitial pneumonia may develope with high prevalence. Another aims of this study is to identify the risk factors developing acute exacerbation during the treatments.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary outcome is to propose the most safe and effective regimens as the first and second lines chemotherapy.
Key secondary outcomes
1) The secondary outcome is to identify the risk factors for developing the acute exacerbation during the treatments.
2) The next outcome is to demonstrate the clinical conditions in patients who sellected the best supportive care as the first line treatment.
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
Idiopathic interstitial pneumonia in patients with advanced stage primary lung cancer, who received chemotherapy or best supportive care as the first line treatment.
Retrospective, medical record basis study.
Key exclusion criteria
Not fulfill the criteria listed above
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuma Kishi, MD, PhD |
Organization
Toranomon Hospital
Division name
Dep. of respiratory center, respiratory medicine
Zip code
Address
2-2-2 Toranomon Minato-ku, Tokyo
TEL
03-3588-1111
kazumak@toranomon.gr.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsushi Miyamoto, MD |
Organization
Toranomon Hospital
Division name
Dep. of respiratory center, respiratory medicine
Zip code
Address
2-2-2 Toranomon Minato-ku, Tokyo
TEL
03-3588-1111
Homepage URL
atsushimotty@gmail.com
Sponsor or person
Institute
The Diffuse Lung Diseases Research Group from the Ministry of Health, Labour, and Welfare in Japan
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Health, Labour and Welfare in 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
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
国家公務員共済組合連合会虎の門病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 09 | 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
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
Main results already published
Date of protocol fixation
| 2015 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 08 | Month | 19 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 14 | Day |
Date of closure to data entry
| 2016 | Year | 12 | Month | 14 | Day |
Date trial data considered complete
| 2016 | Year | 12 | Month | 14 | Day |
Date analysis concluded
Other
Other related information
study design: cohort study
subject: all patients with stageIV or post-operative recurrence lung cancer associated with interstitial pneumonia, by comparison of patients who developed acute exacerbation of interstitial pneumonia during the treatment with who did not develop acute exacerbation.
analysis: patients characteristics, the results of pulmonary function test or HRCT findings, and the prognosis
Management information
Registered date
| 2015 | Year | 07 | Month | 07 | Day |
Last modified on
| 2023 | Year | 07 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021094
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
