UMIN-CTR Clinical Trial

Basic information
Public title	Clinical Significance of Monitoring by Interferon-Gamma Releasing Assay (IGRA) in Patients with Non-Small Cell Lung Cancer receiving Checkpoint Inhibitor Treatment
Acronym	Clinical Significance of Monitoring by Interferon-Gamma Releasing Assay (IGRA) in Checkpoint Inhibitor Treatment
Scientific Title	Clinical Significance of Monitoring by Interferon-Gamma Releasing Assay (IGRA) in Patients with Non-Small Cell Lung Cancer receiving Checkpoint Inhibitor Treatment
Scientific Title:Acronym	Clinical Significance of Monitoring by Interferon-Gamma Releasing Assay (IGRA) in Checkpoint Inhibitor Treatment
Region	Japan

Condition
Condition	Non-Small Cell Lung Cancer
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To Examine between Clinical Outcomes and Interferon-Gamma (IFN-gamma) measured by IGRA in Patients with Non-Small Cell Lung Cancer receiving Immune Checkpoint Inhibitor (ICI) Treatment: Observational prospective study
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Association between IFN-gamm and efficacy, immune-related adverse events, or Hyper progressive Disease in Patients with Non-Small Cell Lung Cancer receiving ICI
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.Unresectable or progressive non-small cell lung Cancer patient treated with ICI alone regardless of the number of the previous regimens. 2.Twenty years old or older patient at registration. 3. Patients with performance status 0-2. 4. Patients with the measurable lesion. 5. Written Informed Consent from the patient
Key exclusion criteria	1.Patient with an active heterochronous or synchronous overlap cancer (carcinoma-insitu or cured intramucosal canceris excluded from overlap cancer) 2 Patient with active liver disease (ex. HBV-DNA positive, autoimmune hepatitis, anliver cirrhosis). 3 Female patient with the possibility (intention) of the pregnancy. Patient whom the Doctor in charge judged to be inappropriate as an object of this study.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Hidekazu Middle name Last name Suzuki
Organization	Osaka Habikino Medical Center
Division name	Thoracic Oncology
Zip code	583-8588
Address	3-7-1 Habikino, Habikino City, Osaka , Japan
TEL	+81-72-957-2121
Email	suzukih@ra.opho.jp

Public contact
Name of contact person	1st name Hidekazu Middle name Last name Suzuki
Organization	Osaka Habikino Medical Center
Division name	Thoracic Oncology
Zip code	583-8588
Address	3-7-1 Habikino, Habikino City, Osaka , Japan
TEL	+81-72-957-2121
Homepage URL
Email	suzukih@ra.opho.jp

Sponsor
Institute	Osaka Prefectural Hospital Organization Osaka Habikino Medical Center
Institute
Department

Funding Source
Organization	Osaka Prefectural Hospital Organization Osaka Habikino Medical 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	Osaka Habikino Medical Center
Address	3-7-1 Habikino, Habikino City, Osaka , Japan
Tel	+81-72-957-2121
Email	kokyucen@ra.opho.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	2018 Year 03 Month 24 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	30
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 03 Month 01 Day
Date of IRB	2018 Year 03 Month 01 Day
Anticipated trial start date	2018 Year 07 Month 10 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Observational study

Management information
Registered date	2018 Year 03 Month 24 Day
Last modified on	2022 Year 10 Month 04 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036351