UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045527 |
|---|---|
| Receipt number | R000050747 |
| Scientific Title | Efficacy and impact on cancer treatment of SARS-CoV-2 vaccination for breast cancer patients: multi-center prospective observational study |
| Date of disclosure of the study information | 2021/09/21 |
| Last modified on | 2022/09/22 11:49:16 |
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Basic information
Public title
Efficacy and impact on cancer treatment of SARS-CoV-2 vaccination for breast cancer patients: multi-center prospective observational study
Acronym
Efficacy and impact on cancer treatment of SARS-CoV-2 vaccination for breast cancer patients: multi-center prospective observational study
Scientific Title
Efficacy and impact on cancer treatment of SARS-CoV-2 vaccination for breast cancer patients: multi-center prospective observational study
Scientific Title:Acronym
Efficacy and impact on cancer treatment of SARS-CoV-2 vaccination for breast cancer patients: multi-center prospective observational study
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Titer of antibody against SARS-CoV-2 S protein in serum after vaccination among breast cancer patients on treatment
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Titer of antibody against SARS-CoV-2 S protein in serum after 4 weeks from vaccination
Key secondary outcomes
Effect on treatment related vaccination
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with pathologically diagnosed breast cancer
2) Patients who are on drug therapy for breast cancer or plan to be on drug therapy at the time of vaccination.
3) Patients who have not been vaccinated with SARS-CoV-2 vaccine and plan to be vaccinated during the enrollment period.
4) Patients aged 20 years or older on the date of enrollment, with a Performance Status (PS) of 0-3
5) Patients who have given written consent to participate in this study
Key exclusion criteria
1) Patients with a history of COVID-19 by the date of study enrollment
2) Patients with inappropriate SARS-CoV-2 vaccination
3) Other patients deemed unsuitable as subjects by the principal investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Mitsuo |
| Middle name | |
| Last name | Terada |
Organization
Nagoya City University
Division name
Department of breast surgery
Zip code
4678602
Address
1, kawasumi, mizuho, Nagoya city, Aichi, Japan
TEL
052-851-5511
breast@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Mitsuo |
| Middle name | |
| Last name | Terada |
Organization
Nagoyacity University
Division name
Department of breast surgery
Zip code
4678602
Address
1, kawasumi, mizuho, Nagoya city, Aichi, Japan
TEL
052-851-5511
Homepage URL
breast@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University
Institute
Department
Personal name
Funding Source
Organization
Nagoya City University
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya City University
Address
1, kawasumi, mizuho, Nagoya city, Aichi, Japan
Tel
052-858-7215
clinical_research@med.nagoya-cu.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 09 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s10549-022-06693-2
Number of participants that the trial has enrolled
85
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
| 2021 | Year | 05 | Month | 14 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 14 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 26 | Day |
Last follow-up date
| 2022 | Year | 05 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study
Management information
Registered date
| 2021 | Year | 09 | Month | 21 | Day |
Last modified on
| 2022 | Year | 09 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050747
