UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of the anti-tumor effects by oligonucleotides among the patients with primary lung cancer
Title of the study (Brief title)	Study of the anti-tumor effects by oligonucleotides among the patients with primary lung cancer
Region	Japan

Condition
Condition	Lung cancer
Classification by specialty	Pneumology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To clarify the anti-tumor immune responses by several oligonucleotides in PBMC or PEMC isolated from the primary lung cancer patients
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	T cell proliferation assay
Key secondary outcomes	Inflammatory cytokines

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	Treatment
Type of intervention	Medicine
Interventions/Control_1	Oligonucleotides
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Diagnosed with primary lung cancer 2. Estimated life expectancy at least three months 3. With written informed consent
Key exclusion criteria	1. Having any treatment for active local or systemic infectious disease 2. Any multiple cancer 3. Needs treatment with systemic corticosteroids or immunosuppressive agents 4. Problematic mental disorder 5. Investigator considers to be inappropriate to participate in this study.
Target sample size	30

Research contact person
Name of lead principal investigator	Nobuaki Kobayashi
Organization	Yokohama City University
Division name	Department of Respiratory Medicine
Address	3-9 Fukuura Kanazawa, Yokohama, JAPAN
TEL	045-787-2630
Email	nkobayas@yokohama-cu.ac.jp

Public contact
Name of contact person	Nobuaki Kobayashi
Organization	Yokohama City University
Division name	Department of Respiratory Medicine
Address	3-9 Fukuura Kanazawa, Yokohama, JAPAN
TEL	045-787-2630
Homepage URL
Email	nkobayas@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University
Institute
Department

Funding Source
Organization	Grants-in-Aid for Scientific Research of Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization	Japan

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	国家公務員共済組合連合会　横浜南共済病院　呼吸器内科（神奈川県）

Other administrative information
Date of disclosure of the study information	2015 Year 06 Month 04 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 08 Month 14 Day
Anticipated trial start date	2012 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2018 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 06 Month 04 Day
Last modified on	2017 Year 06 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020640