UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043918
Receipt number R000050137
Scientific Title A prospective observational study to investigate the safety of SARS-CoV-2 vaccine in patients with lung cancer who are treated or will be treated with anticancer medication (OLCSG2102)
Date of disclosure of the study information 2021/04/14
Last modified on 2023/10/16 12:57:33

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Basic information

Public title

A prospective observational study to investigate the safety of SARS-CoV-2 vaccine in patients with lung cancer who are treated or will be treated with anticancer medication (OLCSG2102)

Acronym

A prospective observational study to investigate the safety of SARS-CoV-2 vaccine in patients with lung cancer who are treated or will be treated with anticancer medication (OLCSG2102)

Scientific Title

A prospective observational study to investigate the safety of SARS-CoV-2 vaccine in patients with lung cancer who are treated or will be treated with anticancer medication (OLCSG2102)

Scientific Title:Acronym

A prospective observational study to investigate the safety of SARS-CoV-2 vaccine in patients with lung cancer who are treated or will be treated with anticancer medication (OLCSG2102)

Region

Japan


Condition

Condition

Lung cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Examining the safety of SARS-CoV-2 vaccination

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Frequency of adverse reactions for 7 days after SARS-CoV-2 vaccination

Key secondary outcomes

Frequency of Grade 3 or higher irAE after SARS-CoV-2 vaccination in patients receiving immune checkpoint inhibitors


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 over 20 years old
2) Patients who can consent to documents
3) Patients diagnosed with advanced / recurrent non-small cell lung cancer or advanced / recurrent small cell lung cancer
4) Patients who are receiving or will be receiving cancer drug therapy
5) Patients scheduled to receive SARS-CoV-2 vaccine

Key exclusion criteria

1) Patients with a history of developing COVID-19
2) Patients with a history of SARS-CoV-2 vaccination
3) Patients who think that it is inappropriate for their doctor to inoculate SARS-CoV-2 vaccine
4) Patients with an estimated prognosis within 2 months

Target sample size

300


Research contact person

Name of lead principal investigator

1st name Tomoki
Middle name
Last name Tamura

Organization

Iwakuni Clinical Center

Division name

Respiratory medicine

Zip code

740-8510

Address

1-1-1, Atago-machi, Iwakuni-shi

TEL

0827-34-1000

Email

tomoki19830211@gmail.com


Public contact

Name of contact person

1st name Toshio
Middle name
Last name Kubo

Organization

Okayama University Hospital

Division name

Clinical Cancer Center

Zip code

700-0914

Address

2-5-1 Shikata-cho, Kita-ku,Okayama-shi

TEL

086-235-7227

Homepage URL


Email

t-kubo@cc.okayama-u.ac.jp


Sponsor or person

Institute

Iwakuni Clinical Center

Institute

Department

Personal name



Funding Source

Organization

Iwakuni Clinical Center

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

Iwakuni Clinical Center

Address

1-1-1, atago-machi, Iwakuni-shi

Tel

0827-34-1000

Email

nomura.chie.ve@mail.hosp.go.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 04 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

500

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

The anti-SARS-CoV-2 mRNA vaccine is safe; however, post-vaccination fever is more common in patients undergoing lung cancer treatment than in healthy individuals.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

No longer recruiting

Date of protocol fixation

2021 Year 04 Month 06 Day

Date of IRB

2021 Year 04 Month 09 Day

Anticipated trial start date

2021 Year 04 Month 09 Day

Last follow-up date

2023 Year 10 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2023 Year 10 Month 31 Day


Other

Other related information

Observe side reactions 7 days after SARS-CoV-2 vaccination.
Observe the expression of irAE for 1 year after SARS-CoV-2 vaccination.


Management information

Registered date

2021 Year 04 Month 14 Day

Last modified on

2023 Year 10 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050137


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name