UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029721 |
|---|---|
| Receipt number | R000033961 |
| Scientific Title | Prophylactic use of inhalation steroid for radiation pneumonitis in patients with subclinical interstitial lung disease: prospective clinical study |
| Date of disclosure of the study information | 2017/10/26 |
| Last modified on | 2023/04/30 09:25:49 |
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Basic information
Public title
Prophylactic use of inhalation steroid for radiation pneumonitis in patients with subclinical interstitial lung disease: prospective clinical study
Acronym
Prophylactic use of inhalation steroid for radiation pneumonitis
Scientific Title
Prophylactic use of inhalation steroid for radiation pneumonitis in patients with subclinical interstitial lung disease: prospective clinical study
Scientific Title:Acronym
Prophylactic use of inhalation steroid for radiation pneumonitis
Region
| Japan |
Condition
Condition
Thoracic malignant disease combined with subclinical interstitial lung disease
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this was to evaluate the efficacy and safety for the prophylactic use of inhalation steroid for radiation pneumonia in patients with subclinical interstitial lung disease.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Occurrence rate of radiation pneumonia
Breathing capacity
CT imaging
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Prophylactic use of inhalation steroid (ciclesonide, daily) during 8 months.
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
| 18 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male
Key inclusion criteria
Histological diagnosis of thoracic cancer
Interstitial lung disease on CT imaging without symptom and treatment history
Key exclusion criteria
Severe heat disease
Active pulmonary disease
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukunori Korogi |
Organization
University of Occupational and Environmental Health
Division name
Department of Radiology
Zip code
Address
Iseigaoka 1-1, Yahatanisi-ku, Kitakyushu-shi 807-8555, Japan.
TEL
093-691-7264
ykorgi@med.uoeh-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takayuki Ohguri |
Organization
University of Occupational and Environmental Health
Division name
Department of Radiology
Zip code
Address
Iseigaoka 1-1, Yahatanisi-ku, Kitakyushu-shi 807-8555, Japan.
TEL
093-691-7264
Homepage URL
ogurieye@med.uoeh-u.ac.jp
Sponsor or person
Institute
University of Occupational and Environmental Health
Institute
Department
Personal name
Funding Source
Organization
University of Occupational and Environmental Health
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 10 | Month | 26 | 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
Completed
Date of protocol fixation
| 2014 | Year | 05 | Month | 20 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 15 | Day |
Anticipated trial start date
| 2014 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 10 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 26 | Day |
Last modified on
| 2023 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033961
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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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