UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Research of genetic polymorphism for the risk of radiation pneumonitis after stereotactic body radiotherapy in lung cancer patients
Title of the study (Brief title)	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	Hiroshi Onishi
Organization	University of Yamanashi
Division name	Department of Radiology
Address	1110 Shimokato Chuo-shi Yamanashi
TEL	055-273-1111
Email	honishi@yamanashi.ac.jp

Public contact
Name of contact person	Hiroshi Onishi
Organization	University of Yamanashi
Division name	Department of Radiology
Address	1110 Shimokato Chuo-shi Yamanashi
TEL	055-273-1111
Homepage URL
Email	honishi@yamanashi.ac.jp

Sponsor
Institute	University of Yamanashi
Institute
Department

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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2013 Year 08 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013540