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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017816
Receipt No. R000020640
Scientific Title Study of the anti-tumor effects by oligonucleotides among the patients with primary lung cancer
Date of disclosure of the study information 2015/06/04
Last modified on 2017/06/02

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Basic information
Public title Study of the anti-tumor effects by oligonucleotides among the patients with primary lung cancer
Acronym Study of the anti-tumor effects by oligonucleotides among the patients with primary lung cancer
Scientific Title Study of the anti-tumor effects by oligonucleotides among the patients with primary lung cancer
Scientific Title:Acronym 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
1st name
Middle name
Last name Nobuaki Kobayashi
Organization Yokohama City University
Division name Department of Respiratory Medicine
Zip code
Address 3-9 Fukuura Kanazawa, Yokohama, JAPAN
TEL 045-787-2630
Email nkobayas@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nobuaki Kobayashi
Organization Yokohama City University
Division name Department of Respiratory Medicine
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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
2012 Year 08 Month 14 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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