UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026964 |
|---|---|
| Receipt number | R000030841 |
| Scientific Title | Evaluation of background lung disease as risk factors of the drug-related interstitial pneumonia induced by the lung cancer chemotherapy |
| Date of disclosure of the study information | 2017/04/15 |
| Last modified on | 2020/04/14 14:50:42 |
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Basic information
Public title
Evaluation of background lung disease as risk factors of the drug-related interstitial pneumonia induced by the lung cancer chemotherapy
Acronym
Risk factors of drug-related interstitial pneumonia by the lung cancer chemotherapy
Scientific Title
Evaluation of background lung disease as risk factors of the drug-related interstitial pneumonia induced by the lung cancer chemotherapy
Scientific Title:Acronym
Risk factors of drug-related interstitial pneumonia by the lung cancer chemotherapy
Region
| Japan |
Condition
Condition
Lung cancer, Interstitial pneumonia
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Verification of better evaluation method of interstitial shadow complicated with primary lung cancer, and the validity of the chemotherapy, using the past information of the study subject
Basic objectives2
Others
Basic objectives -Others
We decided to use HRCT fibrosis score (HFS) applied to idiopathic pulmonary fibrosis (IPF), and Goddard Classification about pulmonary emphysema in addition. We perform the analysis of the CT image by Lung Vision (image analysis software). By these, we verify the evaluation method of the patient of lung cancer complicated with interstitial pneumonia in the background lungs and verify the validity of chemotherapy.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Difference of the frequency of the chemotherapy induced aggravation of interstitial pneumonia between patients with interstitial shadow and without the shadow.
Key secondary outcomes
Frequency of the interstitial shadow in lung cancer patients performed chemotherapy, prognostic difference between with or without interstitial shadow, rate of concordance in observers about an evaluation of the interstitial shadow, rate of concordance of conventional HRCT score, Goddard classification and the evaluation in Lung Vision
Base
Study type
Others,meta-analysis etc
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
Lung cancer patients performed chemotherapy in study entry facilities during from April 1, 2013 to March 31, 2016.
Key exclusion criteria
Refusal by the notices to the Internet, patients that the later information was not provided by changing hospital enough, in addition, patients whom researchers judged to be inappropriate as a study subject.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Mukae |
Organization
Nagasaki University Hospital
Division name
Second Department of Internal Medicine
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki city, Nagasaki prefecture, Japan
TEL
095-819-7273
hmukae@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Gyotoku |
Organization
Nagasaki University Hospital
Division name
Second Department of Internal Medicine
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki-city, Nagasaki, Japan
TEL
095-819-7273
Homepage URL
gyotoku-h@umin.ac.jp
Sponsor or person
Institute
Nagasaki University Hospital, Second Department of Internal Medicine
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University Hospital, Second Department of Internal Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki University Hospital
Address
1-7-1 Sakamoto, Nagasaki-city, Nagasaki, Japan
Tel
095-819-7726
gaibushikin@ml.nagasaki-u.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
| 2017 | Year | 04 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
214
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
| 2017 | Year | 04 | Month | 15 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 28 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 15 | Day |
Last follow-up date
| 2021 | Year | 04 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We accumulate the data backward by cooperative groups
Management information
Registered date
| 2017 | Year | 04 | Month | 12 | Day |
Last modified on
| 2020 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030841
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
