UMIN-CTR Clinical Trial

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
Email	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
Email	kesawada@frontier.hokudai.ac.jp

Sponsor
Institute	Kushiro Rosai Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052022