UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032851
Receipt number R000037450
Scientific Title 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 2022/12/20 15:44:37

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Basic information

Public title

Analysis of tumor-associated antigen expressions and immune responses using clinical samples

Acronym

Analysis of tumor-antigen expressions and immune responses

Scientific Title

Analysis of tumor-associated antigen expressions and immune responses using clinical samples

Scientific Title:Acronym

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

1st name Yoshihiro
Middle name
Last name Miyahara

Organization

Mie University Graduate School of Medicine

Division name

Personalized Cancer Immunotherapy

Zip code

514-8507

Address

2-174, Ebobashi, Tsu, Mie 514-8507 Japan

TEL

059-231-5684

Email

miyahr-y@med.mie-u.ac.jp


Public contact

Name of contact person

1st name Yoshihiro
Middle name
Last name Miyahara

Organization

Mie University Graduate School of Medicine

Division name

Personalized Cancer Immunotherapy

Zip code

514-8507

Address

2-174, Ebobashi, Tsu, Mie 514-8507 Japan

TEL

059-231-5684

Homepage URL


Email

miyahr-y@med.mie-u.ac.jp


Sponsor or person

Institute

Personalized Cancer Immunotherapy, Mie University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Fundings under the agreements between T cell Neuvue 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)



IRB Contact (For public release)

Organization

Ethics Committee in Mie University Hospital

Address

2-174, Ebobashi, Tsu, Mie 514-8507 Japan

Tel

059-231-5045

Email

s-kenkyu@mo.medic.mie-u.ac.jp


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)、大阪国際医療センター(大阪府)、鹿児島大学(鹿児島県)、獨協医科大学(栃木県)


Other administrative information

Date of disclosure of the study information

2018 Year 06 Month 04 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

Open public recruiting

Date of protocol fixation

2018 Year 03 Month 20 Day

Date of IRB

2018 Year 06 Month 04 Day

Anticipated trial start date

2018 Year 06 Month 07 Day

Last follow-up date

2024 Year 09 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

none


Management information

Registered date

2018 Year 06 Month 03 Day

Last modified on

2022 Year 12 Month 20 Day



Link to view the page

Value
https://center6.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