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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032851
Receipt No. R000037450
Official scientific title of the study Analysis of tumor-associated antigen expressions and immune responses using clinical samples
Date of disclosure of the study information 2018/06/04
Last modified on 2018/06/07

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Basic information
Official scientific title of the study Analysis of tumor-associated antigen expressions and immune responses using clinical samples
Title of the study (Brief title) Analysis of tumor-antigen expressions and immune responses
Region
Japan

Condition
Condition malignant tumors, healthy volunteers
Classification by specialty
Medicine in general Hematology and clinical oncology Surgery in general
Pediatrics Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Analysis and evaluation of zing tumor-associated antigen expression on tumor tissues and immune responses in peripheral blood and tumor sites
Basic objectives2 Others
Basic objectives -Others Exploration of prediction biomarker for immunotherapy efficacy
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Tumor antigen expressions
immune responses in peripheral blood and tumor sites(in possible cases)
Key secondary outcomes

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
12 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patient having malignant tuomors (including esophageal cancer, gastric cancer, colon cancer, gynecological cancer, head/neck cancer, urological cancer, bone and soft tissue cancer, and hematological malignancy, et al), who is aged 12 years or older
Healthy volunteer as a control, who is aged 20 years or older
Key exclusion criteria No obtaining an informed consent
Target sample size 120

Research contact person
Name of lead principal investigator Shinichi Kageyama
Organization Mie University Graduate School of Medicine
Division name Immuno-Gene Therapy
Address 2-174, Ebobashi, Tsu, Mie 514-8507 Japan
TEL 059-231-5684
Email kageyama@clin.medic.mie-u.ac.jp

Public contact
Name of contact person Shinichi Kageyama
Organization Mie University Graduate School of Medicine
Division name Immuno-Gene Therapy
Address 2-174, Ebobashi, Tsu, Mie 514-8507 Japan
TEL 059-231-5684
Homepage URL
Email kageyama@clin.medic.mie-u.ac.jp

Sponsor
Institute Immuno-Gene Therapy, Mie University Graduate School of Medicine
Institute
Department

Funding Source
Organization Fundings under the agreements between United Immunty Co. Ltd. and Mie University and between BrightPath Biotherapeutics Co. Ltd. and Mie University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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 名古屋医療センター(愛知県)、東京医科大学(東京都)、産業技術総合研究所(神奈川県)、北海道大学(北海道)

Other administrative information
Date of disclosure of the study information
2018 Year 06 Month 04 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 03 Month 20 Day
Anticipated trial start date
2018 Year 06 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information none

Management information
Registered date
2018 Year 06 Month 03 Day
Last modified on
2018 Year 06 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037450

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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