UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036533 |
|---|---|
| Receipt number | R000035598 |
| Scientific Title | Serial IGRA screening for lung cancer patients receiving immune checkpoint inhibitors |
| Date of disclosure of the study information | 2019/04/22 |
| Last modified on | 2022/05/12 09:25:45 |
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Basic information
Public title
Serial IGRA screening for lung cancer patients receiving immune checkpoint inhibitors
Acronym
IGRA screening for lung cancer patients receiving immune checkpoint inhibitors
Scientific Title
Serial IGRA screening for lung cancer patients receiving immune checkpoint inhibitors
Scientific Title:Acronym
IGRA screening for lung cancer patients receiving immune checkpoint inhibitors
Region
| Japan |
Condition
Condition
non-small cell lung cancer patients who receiving immune checkpoint inhibitors
Classification by specialty
| Pneumology | Infectious disease |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the positive conversion rate of IGRA during immune checkpoint inhibitors therapy.
Basic objectives2
Others
Basic objectives -Others
To evaluate the incidence of active TB during immune checkpoint inhibitors therapy.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
positive conversion rate of IGRA at a year after induction of immune checkpoint inhibitor therapy
Key secondary outcomes
incidence of active TB at a year after induction of immune checkpoint inhibitor therapy
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
Lung cancer patients who receiving immune checkpoint inhibitors
Key exclusion criteria
none
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kohei |
| Middle name | |
| Last name | Fujita |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Respiratory Medicine
Zip code
6128555
Address
1-1, Fukakusa-Mukaihata-Cho, Fushimi-Ku, Kyoto
TEL
0756419161
kfujita-oka@umin.ac.jp
Public contact
Name of contact person
| 1st name | Kohei |
| Middle name | |
| Last name | Fujita |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Respiratory Medicine
Zip code
6128555
Address
1-1, Fukakusa-Mukaihata-Cho, Fushimi-Ku, Kyoto
TEL
0756419161
Homepage URL
kfujita-oka@umin.ac.jp
Sponsor or person
Institute
National Hospital Organization Kyoto Medical Center
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Kyoto Medical Center
Address
1-1, Fukakusa-Mukaihata-Cho, Fushimi-Ku, Kyoto
Tel
0756419161
kfujita-oka@umin.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
国立病院機構京都医療センター（京都府）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 04 | Month | 22 | 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
Main results already published
Date of protocol fixation
| 2018 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 30 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 09 | Month | 30 | Day |
Other
Other related information
To investigate the incidence of positive conversion of IGRA, we will evaluate IGRA before, at 3month, 6month, 12month after treatment with immune checkpoint inhibitors.
Management information
Registered date
| 2019 | Year | 04 | Month | 17 | Day |
Last modified on
| 2022 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035598
