UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of genetic polymorphisms of natural-killer cell associated protein on the risk of lung cancer
Title of the study (Brief title)	The effect of genetic polymorphisms of natural-killer cell associated protein on the risk of lung cancer
Region	Japan

Condition
Condition	Non-small-cell lung cancer
Classification by specialty	Medicine in general Pneumology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	We will conduct a case-control study to evaluate the association between the natural-killer cell associated protein genotypes/haplotypes and the risk of lung cancer.
Basic objectives2	Others
Basic objectives -Others	Genetic risk
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The frequency of genetic polymorphism between case (non-small-cell lung cancer) and control subjects, with regard to natural-killer cell associated protein.
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	<Case> patients with non-small-cell lung cancer <Control> persons who do not have a history of non-small-cell lung cancer
Key exclusion criteria	Subjects who are not able to enroll with written informed consent.
Target sample size	600

Research contact person
Name of lead principal investigator	Shiro Fujita
Organization	Aichi Cancer Center Hospital
Division name	Department of Pathology and Molecular Diagnostics
Address	1-1 Kanokoden, Chikusa-ku Nagoya 464-8681, Japan
TEL	052-762-6111
Email	sfujita@aichi-cc.jp

Public contact
Name of contact person	Fujita Shiro
Organization	Aichi Cancer Center Hospital
Division name	Department of Pathology and Molecular Diagnostics
Address	1-1 Kanokoden, Chikusa-ku Nagoya 464-8681, Japan
TEL	052-762-6111
Homepage URL
Email	sfujita@aichi-cc.jp

Sponsor
Institute	Department of Respiratory Medicine, Graduate School of Medicine, Kyoto University
Institute
Department

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

Other related organizations
Co-sponsor	Institute of Biomedical Research and Innovation
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	2010 Year 09 Month 23 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2010 Year 02 Month 18 Day
Anticipated trial start date	2010 Year 09 Month 01 Day
Last follow-up date	2017 Year 07 Month 31 Day
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	no longer recruiting

Management information
Registered date	2010 Year 09 Month 23 Day
Last modified on	2018 Year 09 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005108