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 | 2024/06/19 19:04:35 |
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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
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
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
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
Published
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
Main results already published
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
| 2024 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050137
