UMIN-CTR Clinical Trial

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
Email	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
Email	gyotoku-h@umin.ac.jp

Sponsor
Institute	Nagasaki University Hospital, Second Department of Internal Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030841