UMIN-CTR Clinical Trial

Basic information
Public title	An evaluation and an examination of the cancer immunology for resectable non-small cell lung cancer
Acronym	IOB-LC2
Scientific Title	An evaluation and an examination of the cancer immunology for resectable non-small cell lung cancer
Scientific Title:Acronym	IOB-LC2
Region	Japan

Condition
Condition	Patients with resectable non-small cell lung cancer who are going to receive pulmonary resection
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	We examine the association of the immunoreaction by the pneumonectomy and the clinical outcome.
Basic objectives2	Others
Basic objectives -Others	We examine biomarkers prescribing the survival and relapse by the pneumonectomy immunologically.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	We study the immune charge of cancer, immune cells, and the neighborhood of cancer microenvironment by pneumonectomy for patients with resecrable non-small-cell lung cancer, and clinical outcome.
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	Patients with advanced non-small-cell lung cancer Patients who are going to receive pulmonary resection Written informed consent is obtained from all the patients.
Key exclusion criteria	Patients having an overlap cancer with activity Patients that an doctor judged to be inappropriate
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Middle name Last name Naruo Yoshimura
Organization	Tohoku Medical and Pharmaceutical University
Division name	Department of pulmonology
Zip code
Address	1-12-1, Komatsushima, Miyaginoku, Sendai, Miyagi 981-8558, JAPAN
TEL	022-259-1221
Email	y-naruo@sc4.so-net.ne.jp

Public contact
Name of contact person	1st name Middle name Last name Naruo Yoshimura
Organization	Tohoku Medical and Pharmaceutical University
Division name	Department of pulmonology
Zip code
Address	1-12-1, Komatsushima, Miyaginoku, Sendai, Miyagi 981-8558, JAPAN
TEL	022-259-1221
Homepage URL
Email	y-naruo@sc4.so-net.ne.jp

Sponsor
Institute	Tohoku Medical and Pharmaceutical University, Tohoku Medical and Pharmaceutical University Hospital
Institute
Department

Funding Source
Organization	Tohoku Medical and Pharmaceutical University, Tohoku Medical and Pharmaceutical University Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2020 Year 02 Month 05 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	Preinitiation
Date of protocol fixation	2018 Year 01 Month 22 Day
Date of IRB
Anticipated trial start date	2018 Year 02 Month 05 Day
Last follow-up date	2022 Year 02 Month 04 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	prospective observation study

Management information
Registered date	2018 Year 02 Month 03 Day
Last modified on	2020 Year 02 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035556