UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017816 |
|---|---|
| Receipt number | 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 19:53:47 |
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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
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
nkobayas@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020640
