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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043305
Receipt No. R000049443
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
Date of disclosure of the study information 2021/02/12
Last modified on 2021/02/11

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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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