UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051800 |
|---|---|
| Receipt number | R000059056 |
| Scientific Title | Prospective study of the usefulness of temporal value of comprehensive geriatric assessment and body composition by bioelectrical impedance analysis in cancer patients. |
| Date of disclosure of the study information | 2023/08/04 |
| Last modified on | 2024/02/01 12:51:32 |
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Basic information
Public title
The usefulness of temporal value of comprehensive geriatric assessment and body composition by bioelectrical impedance analysis in cancer patients.
Acronym
The usefulness of comprehensive geriatric assessment and body composition in patients with advanced cancer.
Scientific Title
Prospective study of the usefulness of temporal value of comprehensive geriatric assessment and body composition by bioelectrical impedance analysis in cancer patients.
Scientific Title:Acronym
Prospective study of the usefulness of comprehensive geriatric assessment and body composition in patients with advanced cancer.
Region
| Japan |
Condition
Condition
cancer
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To prospectively collect comprehensive geriatric assessment and body component analysis by bioelectrical impedance method in cancer patients, and to explore treatment goals for cancer patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Anti-tumor effect and overall geriatric assessment, correlation with body composition analysis results and quality of life.
Key secondary outcomes
The relationship between the results of body component analysis and comprehensive geriatric assessment and treatment related AE.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Measuring and Collecting Body Component Analysis and Elderly Functional Assessment Over Time in Cancer Patients.
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
Adult patients who are scheduled to be examined and treated for cancer at Chiba University Hospital will be included in the study.
Key exclusion criteria
Patients who are judged to be inappropriate for this study by the investigator.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Naoya |
| Middle name | |
| Last name | Kato |
Organization
Chiba University Hospital
Division name
Department of Gastroenterology
Zip code
260-8677
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba
TEL
043-222-7171
kato.naoya@chiba-u.jp
Public contact
Name of contact person
| 1st name | Kazuki |
| Middle name | Amos |
| Last name | Watabe |
Organization
Chiba University Hospital
Division name
Department of Gastroenterology
Zip code
260-8677
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba
TEL
043-222-7171
Homepage URL
kazukiwatabe0211@chiba-u.jp
Sponsor or person
Institute
Department of Gastroenterology, Chiba University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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 Hospital Observational Research Ethics Review Committee
Address
Chiba-ken, Chiba-shi, Chuo-ku, Inohana 1-8-1
Tel
043-222-7171
hsp-kansaturinri@chiba-u.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
HK202305-10
Org. issuing International ID_1
Chiba University Hospital Observational Research Ethics Review Committee
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 08 | Month | 04 | 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
| 2023 | Year | 07 | Month | 19 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 20 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 04 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 08 | Month | 02 | Day |
Last modified on
| 2024 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059056
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
