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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004662
Receipt No. R000005554
Scientific Title Phase I clinical trial of newly developed antigen peptide vaccine for advanced esophageal cancer
Date of disclosure of the study information 2010/12/03
Last modified on 2013/01/29

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Basic information
Public title Phase I clinical trial of newly developed antigen peptide vaccine for advanced esophageal cancer
Acronym Clinical trial of peptide vaccine for esophageal cancer
Scientific Title Phase I clinical trial of newly developed antigen peptide vaccine for advanced esophageal cancer
Scientific Title:Acronym Clinical trial of peptide vaccine for esophageal cancer
Region
Japan

Condition
Condition Advanced esophageal squamous cell carcinoma patietns treated with standart therapy includingn surgery, chemotherapy and radiotherapy, and all these treatments were failed.
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 TO confirm the safety of the newly develped pepatide vaccine for esophageal cancer
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes safety and adverse event of the peptide vaccine
Key secondary outcomes

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 Peptide Vaccine
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
80 years-old >=
Gender Male and Female
Key inclusion criteria Performance status 0-2
Age 20-80 years old
WBC 2000<=, <=15000
PLT 75000<=
GOT <=150
GPT <=150
T-bil <=2.0
Cr <=2.0
HLA-A2402
Obtained written informed concent
Key exclusion criteria Pregnancy
Lactating woman
Severe bleeding tendency
uncontroled infection
concomitant treatment with steroids
patients who are judged inappropriate for eligibility by the investigator
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Matsubara Hisahiro
Organization Graduate School of Medicine, Chiba University
Division name Department of Frontier Surgery
Zip code
Address 1-8-1, Inohana, Chuoku, Chiba
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Graduate School of Medicine, Chiba University
Division name Department of Frontier Surgery
Zip code
Address
TEL 043-222-7171
Homepage URL
Email

Sponsor
Institute Chiba University
Institute
Department

Funding Source
Organization none
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
2010 Year 12 Month 03 Day

Related information
URL releasing protocol
Publication of results Published

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
2010 Year 01 Month 22 Day
Date of IRB
Anticipated trial start date
2010 Year 01 Month 01 Day
Last follow-up date
2012 Year 09 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
2010 Year 12 Month 03 Day
Last modified on
2013 Year 01 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005554

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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