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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036533
Receipt No. 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 2019/06/07

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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
Email 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
Email kfujita-oka@umin.ac.jp

Sponsor
Institute National Hospital Organization Kyoto Medical Center
Institute
Department

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
Email 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 Open public recruiting
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 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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
2019 Year 06 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035598

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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