UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037186 |
|---|---|
| Receipt number | 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 | 2022/12/28 13:46:06 |
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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
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
araim-cib@umin.ac.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
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
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
Completed
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
| 2022 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042386
