UMIN-CTR Clinical Trial

Basic information
Public title	Observational, prospective study to examine the association between values of Bioelectrical impedance analysis (BIA) before and after treatment for cancer, clinical backgrounds, efficiencies of treatment, and adverse events
Acronym	Observational, prospective study to examine the association between values of Bioelectrical impedance analysis (BIA) before and after treatment for cancer, clinical backgrounds, efficiencies of treatment, and adverse events
Scientific Title	Observational, prospective study to examine the association between values of Bioelectrical impedance analysis (BIA) before and after treatment for cancer, clinical backgrounds, efficiencies of treatment, and adverse events
Scientific Title:Acronym	Observational, prospective study to examine the association between values of Bioelectrical impedance analysis (BIA) before and after treatment for cancer, clinical backgrounds, efficiencies of treatment, and adverse events
Region	Japan

Condition
Condition	Lung Cancer
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To examine the association between values of BIA, clinical backgrounds, efficiencies of treatment, and adverse events in lung cancer patients before treatment. *Values of BIA are Body Mass Index (BMI), Soft Lean Mass(SLM), Fat Free Mass Index(FFMI), Skeletal Muscle Mass Index(SMI), phase angle(Ph A), ratio of extracellular water to total body water(ECW/TBW), ratio of extracellular water to intracellular water(ECW/ICW). **Clinical backgrounds are age, sex, Performance Status(PS), smoking history, histologic feature, clinical stage, sites of metastases and previous systemic therapies.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Association between ECW/TBW in BIA and efficiencies or adverse events of anti-cancer treatment
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.Patient who received ICI plus chemotherapyor platinum doublet alone as first-line regimen 2. Patient with recurrence lung cancer or unresectable progression caner 3.Diagnosis of small cell lung cancer or the non-small-cell lung cancer 4.Patient was 20 years oldor morehe at registration 5. Patient with Performance Status 0-2 5. Patient with the evaluable lesion 6. Written informed consent was obtained from the patient
Key exclusion criteria	Patient with a pacemaker
Target sample size	55

Research contact person
Name of lead principal investigator	1st name Tomonori Middle name Last name Hirashima
Organization	Osaka Prefectual Hospital Organization Osaka Habikino Medical Center
Division name	Thoracic Oncology
Zip code	583-8588
Address	3-7-1,Habikino,Habikino-City,Osaka
TEL	0729572121
Email	hirashimat@ra.opho.jp

Public contact
Name of contact person	1st name Tomonori Middle name Last name Hirashima
Organization	Osaka Prefectual Hospital Organization, Osaka Habikino Medical Center
Division name	Thoracic Oncology
Zip code	583-8588
Address	3-7-1,Habikino,Habikino-City,Osaka
TEL	0729572121
Homepage URL
Email	hirashimat@ra.opho.jp

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

Funding Source
Organization	Osaka Prefectual Hospital Organization Osaka Habikino Medical Center
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	Osaka Prefectual Hospital Organization, Osaka Habikino Medical Center
Address	3-7-1,Habikino,Habikino-City,Osaka
Tel	0729572121
Email	takatsur@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	2019 Year 07 Month 29 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	Open public recruiting
Date of protocol fixation	2019 Year 04 Month 15 Day
Date of IRB	2019 Year 05 Month 31 Day
Anticipated trial start date	2019 Year 07 Month 29 Day
Last follow-up date	2022 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	nothing

Management information
Registered date	2019 Year 07 Month 22 Day
Last modified on	2019 Year 08 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042646

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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