UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029726 |
|---|---|
| Receipt number | 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 | 2024/09/16 16:36:43 |
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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
Name of lead principal investigator
| 1st name | Fumito |
| Middle name | |
| Last name | Kuranishi |
Organization
Innoshima-Ishikai Hospital
Division name
Department of Surgery
Zip code
722-2211
Address
Innoshima, Onomichi, Hiroshima 722-2211, Japan
TEL
0845-24-1210
ishikai@beach.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Tadao |
| Middle name | |
| Last name | Ohno |
Organization
Cell-Medicine, Inc.
Division name
Headquarter
Zip code
305-0047
Address
2-1-6 Sengen, Tsukuba, Ibaraki 305-0074, Japan
TEL
029-828-5591
Homepage URL
tad-ohno@cell-medicine.com
Sponsor or person
Institute
Innoshima-Ishikai Hospital
Institute
Department
Personal name
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
IRB, Innoshima-Ishikai Hospital
Address
Innoshima, Onomichi, Hiroshima 722-2211, Japan
Tel
0845-24-1210
ishikai@beach.ocn.ne.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
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
https://doi.org/10.1155/2018/4879406
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1155/2018/4879406
Number of participants that the trial has enrolled
20
Results
In a retrospective analysis, three bone-metastatic breast cancer patients show clinical complete remission who received various treatments, including autologous formalin-fixed tumor vaccine therapy.
Results date posted
| 2024 | Year | 09 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Breast cancer patients of Onomichi General Hospital and Innoshima-Ishikai Hospital.
Participant flow
There is no effective treatment for breast cancer with bone metastasis. In a retrospective analysis, we identified three cases of clinical complete remission (cCR) and long survival among patients with bone metastasis who received various treatments, including autologous formalin-fixed tumor vaccine (AFTV) therapy.
Adverse events
All adverse events were less than CTCAE grade 3.
Outcome measures
Overall survival after the bone metastasis
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
| 2004 | Year | 04 | Month | 24 | Day |
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
| 2024 | Year | 09 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033963
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