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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000036846
Receipt No. R000041976
Scientific Title Study of radiation therapy for lung cancer combined with interstitial lung disease in Japan
Date of disclosure of the study information 2019/05/27
Last modified on 2019/05/24

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Basic information
Public title Study of radiation therapy for lung cancer combined with interstitial lung disease in Japan
Acronym Study of radiation therapy for lung cancer combined with interstitial lung disease in Japan
Scientific Title Study of radiation therapy for lung cancer combined with interstitial lung disease in Japan
Scientific Title:Acronym Study of radiation therapy for lung cancer combined with interstitial lung disease in Japan
Region
Japan

Condition
Condition Lung cancer
Classification by specialty
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify the ratio of patients with interstitial lung disease who have received RT for lung cancer, the incidence of acute exacerbation in such patients, and the risk factors for acute exacerbation.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The ratio of acute exacerbation
Key secondary outcomes The ratio of acute exacerbation related death
The ratio of interstitial lung disease on radiation therapy for lung cancer

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Diagnosed as malignant tumor of lung.
Diagnosed as interstitial lung disease.
Case of radiotherapy.
Key exclusion criteria Patients who have refused to use data.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Yasushi
Middle name
Last name Nagata
Organization Hiroshima University
Division name Radiation Oncology Department
Zip code 734-8551
Address Kasumi 4-9-1, Minami-ku Hiroshima, Japan
TEL 082-257-1545
Email nagat@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name Yasuhito
Middle name
Last name Hagiwara
Organization Yamagata University Faculty of Medicine
Division name Department of Radiation Oncology
Zip code 990-9585
Address Iidanishi 2-2-2, Yamagata, Japan
TEL 023-628-5386
Homepage URL
Email hagiwara.yasuhito@gmail.com

Sponsor
Institute Lung and Mediastinal Tumor Committee of Japanese Radiation Oncology Study Group (JROSG)
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kanagawa Cancer Center IRB
Address Nakao 2-3-2, Asahi-ku, Yokohama, Japan
Tel 045-520-2222
Email chiken-jimu4@kcch.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
2019 Year 05 Month 27 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 67
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
2016 Year 08 Month 31 Day
Date of IRB
2016 Year 09 Month 08 Day
Anticipated trial start date
2016 Year 09 Month 08 Day
Last follow-up date
2018 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2019 Year 05 Month 24 Day
Last modified on
2019 Year 05 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041976

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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