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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029726
Receipt No. R000033963
Scientific Title Effect of autologous formalin-fixed tumor vaccine on bone-metastatic breast cancer - A retrospective study
Date of disclosure of the study information 2017/10/30
Last modified on 2017/10/26

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Basic information
Public title Effect of autologous formalin-fixed tumor vaccine on bone-metastatic breast cancer - A retrospective study
Acronym Autologous formalin-fixed tumor vaccine on bone-metastatic breast cancer
Scientific Title Effect of autologous formalin-fixed tumor vaccine on bone-metastatic breast cancer - A retrospective study
Scientific Title:Acronym Autologous formalin-fixed tumor vaccine on bone-metastatic breast cancer
Region
Japan

Condition
Condition Bone-metastatic breast cancer
Classification by specialty
Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Description of an overall survival curve on bone-metastatic breast cancer patients treated with autologous formalin-fixed tumor vaccine.
Basic objectives2 Others
Basic objectives -Others No description has been published on the overall survival curve of tumor-vaccine-treated bone-metastatic breast cancer patients.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Overall survival time (from the date of initial diagnosis of bone metastasis to the date of death)
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 Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Adjuvant treatment with autologous formalin-fixed tumor vaccine on routine medical care. 3-6 intradermal injections for 6-12 weeks.
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 Female
Key inclusion criteria - Patients whose primary lesion of the breast cancer has been resected before or at the first diagnosis of bone metastasis and who desired adjuvant treatment with AFTV on their own expense.
- Outpatient
Key exclusion criteria None
Target sample size 20

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Fumito Kuranishi
Organization Innoshima-Ishikai Hospital
Division name Department of Surgery
Zip code
Address Innoshima, Onomichi, Hiroshima 722-2211, Japan
TEL 0845-24-1210
Email ishikai@beach.ocn.ne.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Tadao Ohno
Organization Cell-Medicine, Inc.
Division name Headquarter
Zip code
Address 2-1-6 Sengen, Tsukuba, Ibaraki 305-0074, Japan
TEL 029-828-5591
Homepage URL
Email tad-ohno@cell-medicine.com

Sponsor
Institute Innoshima-Ishikai Hospital
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 因島医師会病院(広島県)   Innoshima-Ishikai Hospital (Hiroshima)

Other administrative information
Date of disclosure of the study information
2017 Year 10 Month 30 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
2004 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2004 Year 10 Month 14 Day
Last follow-up date
2017 Year 08 Month 26 Day
Date of closure to data entry
2017 Year 09 Month 26 Day
Date trial data considered complete
2017 Year 09 Month 26 Day
Date analysis concluded
2017 Year 09 Month 26 Day

Other
Other related information

Management information
Registered date
2017 Year 10 Month 26 Day
Last modified on
2017 Year 10 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033963

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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