UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004006 |
|---|---|
| Receipt number | R000004809 |
| Scientific Title | Phase I clinical study of peptide vaccine using Cancer-Testis antigen against advanced esophageal cancer |
| Date of disclosure of the study information | 2010/08/06 |
| Last modified on | 2014/05/30 17:16:20 |
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Basic information
Public title
Phase I clinical study of peptide vaccine using Cancer-Testis antigen against advanced esophageal cancer
Acronym
CT antigen vaccine to advanced esophageal cancer
Scientific Title
Phase I clinical study of peptide vaccine using Cancer-Testis antigen against advanced esophageal cancer
Scientific Title:Acronym
CT antigen vaccine to advanced esophageal cancer
Region
| Japan |
Condition
Condition
Advanced esophageal squamous cell carcinoma refractory to standard therapeutic modality
Classification by specialty
| Medicine in general | Gastroenterology | Surgery in general |
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the safety and adverse event.
This clinical study collaborated with Prof. Yusuke Nakamura, Institute of Medical Science, the University of Tokyo.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
To evaluate the safety and adverse event.
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 vaccination
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
(1)Performance status 0-2
(2Age 20 to 80 years-old
(3)WBC<=2000,>=15000
PLT<=75000
GOT>=150
GPT>=150
T-bil>=2.0
Cr>=2.0
(4)HLA-A2402 positive
(5)Obtains written informed concent
Key exclusion criteria
(1)Pregnant woman
(2)Lactating woman
(3)Severe bleeding tendency
(4)Uncontrolled infection
(5)Concomitant treatment with steroids
(6)patients who are judged inappropriate for the entry into study by the investigator
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideaki Shimada |
Organization
Toho University School of Medicine
Division name
Division of general and gastroenterological surgery, Department of Surgery (Omori)
Zip code
Address
6-11-1 Omori-Nishi, Ota-ku, Tokyo 143-8541. Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Yajima |
Organization
Toho University School of Medicine
Division name
Division of general and gastroenterological surgery, Department of Surgery (Omori)
Zip code
Address
6-11-1 Omori-Nishi, Ota-ku, Tokyo 143-8541. Japan
TEL
Homepage URL
Sponsor or person
Institute
Toho University
Institute
Department
Personal name
Funding Source
Organization
Toho 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
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 | 08 | Month | 06 | 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
| 2010 | Year | 07 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 08 | 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
Management information
Registered date
| 2010 | Year | 08 | Month | 06 | Day |
Last modified on
| 2014 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004809
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
