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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000044213
Receipt No. R000050488
Scientific Title A prospective observational study to investigate the safety of SARS-Cov-2 vaccine for patients with advanced lung cancer who are treated with immune checkpoint inhibitor.
Date of disclosure of the study information 2021/05/14
Last modified on 2021/05/14

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Basic information
Public title A prospective observational study to investigate the safety of SARS-Cov-2 vaccine for patients with advanced lung cancer who are treated with immune checkpoint inhibitor.
Acronym Association between immune related adverse events and novel coronavirus vaccine for advanced lung cancer patients
Scientific Title A prospective observational study to investigate the safety of SARS-Cov-2 vaccine for patients with advanced lung cancer who are treated with immune checkpoint inhibitor.
Scientific Title:Acronym Association between immune related adverse events and novel coronavirus vaccine for advanced lung cancer patients
Region
Japan

Condition
Condition Lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to investigate the safety of SARS-Cov-2 vaccine for lung cancer patients who are treated with immune checkpoint inhibitor.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The frequency of adverse events related with immune checkpoint inhibitor in 3 months after the vaccination.
Key secondary outcomes The frequency of adverse events related with immune checkpoint inhibitor in 6 months after the vaccination.
The frequency of adverse reactions after the vaccination
The rate of vaccination during the observation period of this study.
The rate of infection for COVID-19 after the 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 Patients who have NSCLC with histologically or cytologically confirmed

Patients who have locally advanced, metastatic or recurrent lung cancer

Patients who are treated/will be treated with immune checkpoint inhibitor

Patients who have willing to receive the SARS-Cov-2 vaccine, but have not yet been vaccinated

Patients are enrolled if they are over 20 years old

Patients are enrolled if they can write written consent form after they listen the explanation of this study and consent the study.
Key exclusion criteria Patients that doctor in charge consider them inappropriate as a subject

Patients who had already infected with COVID-19
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Shoko
Middle name
Last name Kawai
Organization Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Division name Department of Respiratory Medicine
Zip code 113-0021
Address 3-18 Honkomagome, Bunkyo-ku, Tokyo,Japan
TEL 03-3823-2101
Email river.happiness@cick.jp

Public contact
Name of contact person
1st name Shoko
Middle name
Last name Kawai
Organization Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Division name Department of Respiratory Medicine
Zip code 113-0021
Address 3-18 Honkomagome, Bunkyo-ku, Tokyo,Japan
TEL 03-3823-2101
Homepage URL
Email river.happiness@cick.jp

Sponsor
Institute Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Institute
Department

Funding Source
Organization Self funding
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 Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Address 3-18 Honkomagome, Bunkyo-ku, Tokyo,Japan
Tel 03-3823-2101
Email river.happiness@cick.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 05 Month 14 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 Enrolling by invitation
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 14 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The frequency of adverse events related with immune checkpoint inhibitor in 3 months after the vaccination.

The frequency of adverse events related with immune checkpoint inhibitor in 6 months after the vaccination.
The frequency of adverse reactions after the vaccination
The rate of vaccination during the observation period of this study.
The rate of infection for COVID-19 after the vaccination

Management information
Registered date
2021 Year 05 Month 14 Day
Last modified on
2021 Year 05 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050488

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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