UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036846 |
|---|---|
| Receipt number | 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 23:15:00 |
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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
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
hagiwara.yasuhito@gmail.com
Sponsor or person
Institute
Lung and Mediastinal Tumor Committee of Japanese Radiation Oncology Study Group (JROSG)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041976
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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