UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000026964
Receipt No. 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 2018/10/14

* 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 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
Middle name
Last name Hiroshi Mukae
Organization Nagasaki University Hospital
Division name Second Department of Internal Medicine
Zip code
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
Middle name
Last name Hiroshi Gyotoku
Organization Nagasaki University Hospital
Division name Second Department of Internal Medicine
Zip code
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
Address
Tel
Email

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 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 Suspended
Date of protocol fixation
2017 Year 04 Month 15 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 15 Day
Last follow-up date
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
2018 Year 10 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030841

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.