UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011576 |
|---|---|
| Receipt number | R000013540 |
| Scientific Title | Research of genetic polymorphism for the risk of radiation pneumonitis after stereotactic body radiotherapy in lung cancer patients |
| Date of disclosure of the study information | 2013/09/01 |
| Last modified on | 2017/05/17 18:38:27 |
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Basic information
Public title
Research of genetic polymorphism for the risk of radiation pneumonitis after stereotactic body radiotherapy in lung cancer patients
Acronym
Genetic polymorphism for the risk of radiation pneumonitis after stereotactic body radiotherapy
Scientific Title
Research of genetic polymorphism for the risk of radiation pneumonitis after stereotactic body radiotherapy in lung cancer patients
Scientific Title:Acronym
Genetic polymorphism for the risk of radiation pneumonitis after stereotactic body radiotherapy
Region
| Japan |
Condition
Condition
non-small cell lung cancer
Classification by specialty
| Medicine in general | Pneumology | Surgery in general |
| Chest surgery | Radiology | Adult |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To research correlations of the genetic polymorphism affectiong inflammation such as TGF-beta 1 with radiation pneumonitis after stereotactic body radiotherapy for lung cancer
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Discovery of the type of genetic polymorphism as the risk factors of radiation pneumonitis after stereotactic body radiotherapy for lung cancer
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
pathology proven lung cancer in principle but including pathology-unproven clinically diagnosed non-small cell lung cancer
previously treated or treatment planned with stereotactic body radiotherapy
written informed consent can be acquired
Key exclusion criteria
written informed consent can't be acquired
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Onishi |
Organization
University of Yamanashi
Division name
Department of Radiology
Zip code
Address
1110 Shimokato Chuo-shi Yamanashi
TEL
055-273-1111
honishi@yamanashi.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Onishi |
Organization
University of Yamanashi
Division name
Department of Radiology
Zip code
Address
1110 Shimokato Chuo-shi Yamanashi
TEL
055-273-1111
Homepage URL
honishi@yamanashi.ac.jp
Sponsor or person
Institute
University of Yamanashi
Institute
Department
Personal name
Funding Source
Organization
Grants in aid for Scientific Research
Organization
Division
Category of Funding Organization
Non profit foundation
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
| 2013 | Year | 09 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 08 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Materials: Patients who were treated or scheduled with stereotactic body radiotheray for their lung cancer
Case group: patients who developed radiation pneumonitis > or = grade 2
Control group: patients who didn't develop radiation pneumonitis > or = grade 2
Analysis: Corrlelation as a risk factor of their genetic polyphism to the occurence of radiation pneumonitis, that is analyzed togerher with other factors of their backgrounds and treatment.
Management information
Registered date
| 2013 | Year | 08 | Month | 26 | Day |
Last modified on
| 2017 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013540
