UMIN-CTR Clinical Trial

Basic information
Public title	Retrospective study of the relationship between the effects of immunotherapy and background factors such as BMI in patients with advanced / recurrent non-small cell lung cancer
Acronym	IO-BMI study
Scientific Title	Retrospective study of the relationship between the effects of immunotherapy and background factors such as BMI in patients with advanced / recurrent non-small cell lung cancer
Scientific Title:Acronym	Retrospective study of the relationship between the effects of immunotherapy and background factors such as BMI in patients with advanced / recurrent non-small cell lung cancer
Region	Japan

Condition
Condition	Patients that diagnosed as advanced / recurrent non-small cell lung cancer, and received immunotherapy at our hospital
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	We explore the relationship between the effects of immunotherapy and BMI before treatment in patients with advanced / recurrent non-small cell lung cancer.
Basic objectives2	Others
Basic objectives -Others	We explore the relationship between the effects of immunotherapy and background factors before treatment in patients with advanced / recurrent non-small cell lung cancer.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Relationship between overall survival and pretreatment BMI
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	A patient diagnosed as advanced / recurrent non-small cell lung cancer. A patient in which immunotherapy (immune checkpoint inhibitor alone or combined immunotherapy using a combination of immune checkpoint inhibitor and chemotherapy) was performed in our hospital.
Key exclusion criteria	A patient in which information on background factors such as effects and BMI cannot be collected
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Naruo Middle name Last name Yoshimura
Organization	Tohoku Medical and Pharmaceutical University, Faculty of Medicine
Division name	Division of Respiratory Medicine
Zip code	983-8536
Address	1-15-1, Komatsushima, Miyaginoku, Sendai, Miyagi, JAPAN
TEL	022-290-8850
Email	y-naruo@sc4.so-net.ne.jp

Public contact
Name of contact person	1st name Naruo Middle name Last name Yoshimura
Organization	Tohoku Medical and Pharmaceutical University, Faculty of Medicine
Division name	Division of Respiratory Medicine
Zip code	983-8536
Address	1-15-1, Komatsushima, Miyaginoku, Sendai, Miyagi, JAPAN
TEL	0222908850
Homepage URL	https://www.hosp.tohoku-mpu.ac.jp/center/cr_support_center/disclosure.html
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	Tohoku Medical and Pharmaceutical University, Faculty of Medicine
Address	1-15-1, Komatsushima, Miyaginoku, Sendai, Miyagi, JAPAN
Tel	0222908850
Email	y-naruo@sc4.so-net.ne.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	2021 Year 02 Month 12 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	2021 Year 02 Month 03 Day
Date of IRB	2021 Year 02 Month 04 Day
Anticipated trial start date	2021 Year 03 Month 01 Day
Last follow-up date	2021 Year 04 Month 30 Day
Date of closure to data entry	2021 Year 05 Month 31 Day
Date trial data considered complete	2021 Year 05 Month 31 Day
Date analysis concluded	2021 Year 06 Month 30 Day

Other
Other related information	Retrospective observational study

Management information
Registered date	2021 Year 02 Month 11 Day
Last modified on	2021 Year 02 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049443

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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