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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000037186
Receipt No. R000042386
Scientific Title Analysis of Correlation between Mass of Muscle/Fat and Tolerability of Chemotherapy in Patients with Advanced Cancer
Date of disclosure of the study information 2019/06/26
Last modified on 2019/06/26

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Basic information
Public title Analysis of Correlation between Mass of Muscle/Fat and Tolerability of Chemotherapy in Patients with Advanced Cancer
Acronym Correlation between Mass of Muscle/Fat and Tolerability of Chemotherapy
Scientific Title Analysis of Correlation between Mass of Muscle/Fat and Tolerability of Chemotherapy in Patients with Advanced Cancer
Scientific Title:Acronym Correlation between Mass of Muscle/Fat and Tolerability of Chemotherapy
Region
Japan

Condition
Condition Patients with Advanced Cancer
Classification by specialty
Medicine in general
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluation the correlation between mass of muscle/fat and tolerability of chemotherapy
Basic objectives2 Others
Basic objectives -Others Evaluation the correlation
Trial characteristics_1 Others
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Correlation between
(1)Mass of muscle/fat and their change
and
(2)severe AEs, PS, change of regimen,dose reduction, BSC, prognosis.
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 (1)Advanced cancer
(2)Chemotherapy
Key exclusion criteria Patients who decline mass of muscle/fat
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Makoto
Middle name
Last name Arai
Organization Chiba University
Division name Clinical Oncology
Zip code 260-8670
Address Inohana 1-8-1, Chuo-ku, Chiba City
TEL 043-222-7171
Email araim-cib@umin.ac.jp

Public contact
Name of contact person
1st name Makoto
Middle name
Last name Arai
Organization Chiba University
Division name Clinical Oncology
Zip code 260-8670
Address Inohana 1-8-1, Chuo-ku, Chiba City
TEL 043-222-7171
Homepage URL
Email araim-cib@umin.ac.jp

Sponsor
Institute Chiba University
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Chiba University
Address Inohana 1-8-1, Chuo-ku, Chiba City
Tel 043-222-7171
Email araim_cib@yahoo.co.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 06 Month 26 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 Enrolling by invitation
Date of protocol fixation
2019 Year 03 Month 15 Day
Date of IRB
2019 Year 04 Month 23 Day
Anticipated trial start date
2019 Year 06 Month 27 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We evaluate the correlation between the data of mass of muscle/fat and events associated with chemotherapy.

Management information
Registered date
2019 Year 06 Month 26 Day
Last modified on
2019 Year 06 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042386

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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