UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045571 |
|---|---|
| Receipt number | R000052022 |
| Scientific Title | Cohort study of investigation of SARS-CoV-2 antibody after vaccination in patients with or without cancer |
| Date of disclosure of the study information | 2021/09/30 |
| Last modified on | 2021/09/25 22:52:05 |
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Basic information
Public title
Cohort study of investigation of SARS-CoV-2 antibody after vaccination in patients with or without cancer
Acronym
Cohort study of SARS-CoV-2 antibody after vaccination
Scientific Title
Cohort study of investigation of SARS-CoV-2 antibody after vaccination in patients with or without cancer
Scientific Title:Acronym
Cohort study of SARS-CoV-2 antibody after vaccination
Region
| Japan |
Condition
Condition
Cancer
Classification by specialty
| Medicine in general |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine alteration of SARS-CoV-2 antibody after vaccination.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Positive rate of SARS-CoV-2 antibody after 6 weeks of vaccination
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who are planned to receive SARS-CoV-2 vaccine.
Key exclusion criteria
Patients who are judged inappropriate for study by investigator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kentaro |
| Middle name | |
| Last name | Sawada |
Organization
Kushiro Rosai Hospital
Division name
Department od Medical oncology
Zip code
085-8533
Address
13-23, Nakazono-cho, Kushiro-shi, Hokkaido
TEL
0154227191
kesawada@frontier.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Sawada |
Organization
Kushiro Rosai Hospital
Division name
Department of Medical Oncology
Zip code
085-8533
Address
13-23, Nakazono-cho, Kushiro-shi, Hokkaido
TEL
0154227191
Homepage URL
kesawada@frontier.hokudai.ac.jp
Sponsor or person
Institute
Kushiro Rosai Hospital
Institute
Department
Personal name
Funding Source
Organization
Kushiro Rosai Hospital
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
Kushiro Rosai Hospital
Address
13-23, Nakazono-cho, Kushiro-shi, Hokkaido
Tel
0154-22-7191
kesawada@frontier.hokudai.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 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 05 | Month | 11 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 24 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2021 | Year | 09 | Month | 25 | Day |
Last modified on
| 2021 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052022
