UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047380 |
|---|---|
| Receipt number | R000054042 |
| Scientific Title | A prospective study of the efficacy and the safety of the COVID-19 vaccines in NSCLC patients with UFT as postoperative adjuvant chemotherapy |
| Date of disclosure of the study information | 2022/04/04 |
| Last modified on | 2023/04/05 21:55:42 |
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Basic information
Public title
A prospective study of the efficacy and the safety of the COVID-19 vaccines in NSCLC patients with UFT as postoperative adjuvant chemotherapy
Acronym
A prospective study of the efficacy and the safety of the COVID-19 vaccines in NSCLC patients with UFT as postoperative adjuvant chemotherapy
Scientific Title
A prospective study of the efficacy and the safety of the COVID-19 vaccines in NSCLC patients with UFT as postoperative adjuvant chemotherapy
Scientific Title:Acronym
A prospective study of the efficacy and the safety of the COVID-19 vaccines in NSCLC patients with UFT as postoperative adjuvant chemotherapy
Region
| Japan |
Condition
Condition
Non-small-cell lung cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy and the safety of SARS-CoV-2 vaccines in non-small-cell lung cancer patients with UFT as postoperative adjuvant chemotherapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The IgG against the S1 subunit of spike protein
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
1. Patients who plan to receive SARS-CoV-2 vaccines or within three months after the second dose of SARS-CoV-2 vaccines.
2. Patients who receive complete resection of NSCLC.
3. Patients who are over 20 years old.
4. Patients who submit written informed consent
Key exclusion criteria
1. Patients who have a history of COVID-19.
2. Patients who have any other infectious diseases under treatment.
3. Patients who receive immunosuppressive agents
4. Patients who receive treatment for other malignant diseases.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yugo |
| Middle name | |
| Last name | Tanaka |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Thoracic Surgery
Zip code
650-0017
Address
7-5-2 Kusunoki-cho, Chuou-ku, Kobe, Hyogo, Japan 650-0017
TEL
078-382-5750
tanakay@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Megumi |
| Middle name | |
| Last name | Nishikubo |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Thoracic Surgery
Zip code
650-0017
Address
7-5-2 Kusunoki-cho, Chuou-ku, Kobe, Hyogo, Japan 650-0017
TEL
078-382-5750
Homepage URL
megumin@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
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
Clinical Research Area Ethics Committee of Kobe University Graduate School of Medicine
Address
7-5-2 Kusunoki-cho, Chuou-ku, Kobe, Hyogo, Japan 650-0017
Tel
078-382-6669
chiken@med.kobe-u.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
| 2022 | Year | 04 | Month | 04 | 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
40
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
Completed
Date of protocol fixation
| 2021 | Year | 07 | Month | 16 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 16 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 17 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing patiular
Management information
Registered date
| 2022 | Year | 04 | Month | 04 | Day |
Last modified on
| 2023 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054042
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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