UMIN-ICDS 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

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 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

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

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/icdr_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