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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021866
Receipt No. 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

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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
Last 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
Email teramoto@belle.shiga-med.ac.jp

Public contact
1st 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
Email teramoto@belle.shiga-med.ac.jp

Sponsor
Institute Shiga University of Medical Science
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025211

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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