UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021866 |
|---|---|
| Receipt number | R000025211 |
| Scientific Title | The Retrospective Study of MUC1-targeted Dendritic Cell-based Vaccine in Patients with Refractory Non-small Cell Lung Cancer |
| Date of disclosure of the study information | 2016/04/12 |
| Last modified on | 2016/04/11 16:02:47 |
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Basic information
Public title
The Retrospective Study of MUC1-targeted Dendritic Cell-based Vaccine in Patients with Refractory Non-small Cell Lung Cancer
Acronym
MUC1-targeted Dendritic Cell-based Vaccine in Patients with Refractory Non-small Cell Lung Cancer
Scientific Title
The Retrospective Study of MUC1-targeted Dendritic Cell-based Vaccine in Patients with Refractory Non-small Cell Lung Cancer
Scientific Title:Acronym
MUC1-targeted Dendritic Cell-based Vaccine in Patients with Refractory Non-small Cell Lung Cancer
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety and efficacy of MUC1-targeted dendritic cell-based vaccine in patients with refractory non-small cell lung cancer, retrospectively.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficacy (Overall survival from the initial vaccination)
Key secondary outcomes
Safety(Incidence and grade of adverse events)
Anti-tumor effect after the six vaccinations
Immunological responses after the six vaccinations (MUC1-specific cytotoxicity and frequency of regulatory T cells in peripheral blood)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Between August 2005 and May 2015, NSCLC patients who were treated with MUC1-targeted dendritic cell-based vaccines as an advanced medical treatment approved by the Ministry of Health, Labor and Welfare, Japan, in Shiga University of Medical Science Hospital.
Key exclusion criteria
Patients with NSCLC that was not refractory for some standard cancer treatments.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koji Teramoto |
Organization
Shiga University of Medical Science
Division name
Department of Medical Oncology
Zip code
Address
Seta-Tsukinowa, Otsu, Shiga
TEL
077-548-3590
teramoto@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koji Teramoto |
Organization
Shiga University of Medical Science
Division name
Department of Medical Oncology
Zip code
Address
Seta-Tsukinowa, Otsu, Shiga
TEL
077-548-3590
Homepage URL
teramoto@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Shiga University of Medical Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | Month | 12 | 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
| 2015 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To Evaluate an association between overall survival time form the initial vaccination and immune-related adverse events or frequency of peripheral lymphocytes.
Management information
Registered date
| 2016 | Year | 04 | Month | 11 | Day |
Last modified on
| 2016 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025211
