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Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000000775
Receipt No. R000000934
Scientific Title Dendritic cell therapy and intratumor dendritic cell injection therapy using Tumor associated antigen or tumor lysate for patients with advanced and recurrent cancer
Date of disclosure of the study information 2007/08/01
Last modified on 2007/07/25

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Basic information
Public title Dendritic cell therapy and intratumor dendritic cell injection therapy using Tumor associated antigen or tumor lysate for patients with advanced and recurrent cancer
Acronym Dendritic cell therapy for patients with advanced cancer
Scientific Title Dendritic cell therapy and intratumor dendritic cell injection therapy using Tumor associated antigen or tumor lysate for patients with advanced and recurrent cancer
Scientific Title:Acronym Dendritic cell therapy for patients with advanced cancer
Region
Japan

Condition
Condition advanced and recurrent cancer
Classification by specialty
Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Safety and effectiveness
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes safety
Key secondary outcomes effectiveness

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
Vaccine
Interventions/Control_1 cell therapy
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria advanced and recurrent cancer
PS:0-2
No infection
1. 3500<WBC<12,000/cmm
2. platelet>100,000/cmm
3. No severe liver dysfuntion
4. T-Bil<2.0mg/dl
5. UN<25mg/dl
6. Creatinin<1.5mg/dl
7. 24hr Ccr>50ml/min
after completion of informed consent
8. normal ECG
Key exclusion criteria Pregnancy
Severe Psychiatric disoreder
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ohto Hitoshi
Organization Fukushima Medical University
Division name Dept. of Blood transfusion and Transplantation
Zip code
Address Hikarigaoka 1, Fukushima
TEL 024-547-1111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Ohto Hitoshi
Organization Fukushima Medical University
Division name Dept. of Blood transfusion and Transplantation
Zip code
Address 024-547-1111
TEL
Homepage URL
Email

Sponsor
Institute Fukushima Medical University
Institute
Department

Funding Source
Organization Fukushima Medical University
Organization
Division
Category of Funding Organization Self funding
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
2007 Year 08 Month 01 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
Date of protocol fixation
2007 Year 07 Month 25 Day
Date of IRB
Anticipated trial start date
2007 Year 08 Month 01 Day
Last follow-up date
2009 Year 07 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2007 Year 07 Month 25 Day
Last modified on
2007 Year 07 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000934

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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