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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000047665
Receipt No. R000054348
Scientific Title Assessment of the Effectiveness of HER2 Vaccine Therapy
Date of disclosure of the study information 2022/05/06
Last modified on 2022/05/09

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Basic information
Public title Molecular Targeted Vaccine Therapy for Cancer
Acronym Molecular Targeted Vaccine Therapy for Cancer
Scientific Title Assessment of the Effectiveness of HER2 Vaccine Therapy
Scientific Title:Acronym HER2 Vaccine Therapy
Region
Japan

Condition
Condition Esophageal Cancer, Gastric Cancer, Breast Cancer, Colorectal Cancer, Bladder Cancer, Biliary Tract Cancer
Classification by specialty
Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine
Endocrinology and Metabolism Hematology and clinical oncology Surgery in general
Gastrointestinal surgery Hepato-biliary-pancreatic surgery Endocrine surgery
Breast surgery Obsterics and gynecology Urology
Laboratory medicine Operative medicine Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Assess the efficacy of HER2 vaccine therapy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Serum HER2 concentration
Tumor marker concentrations
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 Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Vaccine
Interventions/Control_1 Injection of HER2 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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Must have histologically confirmed solid tumor
2. Women must not be pregnant
3. Doesn't have heart disease
4. Ability to understand and the willingness to sign a written informed consent document; the patient must be aware that his/her disease is neoplastic in nature and willingly consent after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks, and discomforts
Key exclusion criteria 1. Patients with intracranial bleeding
2. Patients who have evidence of active infection that requires antibiotic therapy; patients must have been off antibiotic treatment for at least 3 weeks prior to initiating treatment
3. Patients with known active human immunodeficiency virus (HIV), hepatitis A, hepatitis B, or hepatitis C infection
4. Patients with serious cardiopulmonary disorders, including congestive heart failure, symptomatic coronary artery disease, serious cardiac arrhythmia, and symptomatic chronic obstructive pulmonary disease or patients with other serious uncontrolled medical diseases
5. Patients who require or likely to require corticosteroids or other immunosuppressives for intercurrent disease are NOT eligible
6. Splenectomized patients
7. Autoimmune diseases including rheumatoid arthritis, systemic lupus erythematosus, scleroderma, polymyositis dermatomyositis, or a vasculitic syndrome
8. Patients who have developed anaphylactic responses to other vaccines
9. History of congestive heart failure, coronary artery disease and myocardial infarction; active or unstable cardiovascular disease or cardiac disease requiring drug or device intervention
10. Patients on HER2 targeted therapies, such as Herceptin, Perjeta, Kadcyla, and Enhertu.
Target sample size 88

Research contact person
Name of lead principal investigator
1st name Takayoshi
Middle name
Last name Ubuka
Organization International Cancer Laboratory Co., Ltd.
Division name Division of Research Initiatives and Development
Zip code 104-0014
Address 2nd Floor, No. 3 Toho Bldg. 1-6-8 Shintomi, Chuo-ku, Tokyo
TEL 03-6426-0316
Email t.ubuka@ic-lab.jp

Public contact
Name of contact person
1st name Ubuka
Middle name
Last name Takayoshi
Organization International Cancer Laboratory Co., Ltd.
Division name Division of Research Initiatives and Development
Zip code 104-0014
Address 2nd Floor, No. 3 Toho Bldg. 1-6-8 Shintomi, Chuo-ku, Tokyo
TEL 03-6426-0316
Homepage URL
Email t.ubuka@ic-lab.jp

Sponsor
Institute International Cancer Laboratory Co., Ltd.
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 Nihonbashi Sakura Clinic IRB
Address 5th Floor Inamura Bldg. 1-9-2 Kayabacho Nihonbashi Chuo-ku, Tokyo
Tel 03-6661-9061
Email c-irb_ug@neues.co.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 名古屋がん中央クリニック(愛知県)
医療法人知慎会 JTKクリニック(東京都)

Other administrative information
Date of disclosure of the study information
2022 Year 05 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 Open public recruiting
Date of protocol fixation
2022 Year 04 Month 27 Day
Date of IRB
2022 Year 04 Month 27 Day
Anticipated trial start date
2022 Year 05 Month 06 Day
Last follow-up date
2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2022 Year 05 Month 06 Day
Last modified on
2022 Year 05 Month 09 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054348

Research Plan
Registered date File name
2022/05/09 研究計画書 第5版(2022年4月27日修正).pdf

Research case data specifications
Registered date File name

Research case data
Registered date File name


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