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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000037451
Receipt No. R000042646
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
Date of disclosure of the study information 2019/07/29
Last modified on 2019/08/29

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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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