UMIN-CTR Clinical Trial

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