UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024395 |
|---|---|
| Receipt number | R000028080 |
| Scientific Title | Prospective evaluation of the factors in geriatric assessment for predicting the vulnerability of the elderly patients in out-patient chemotherapy |
| Date of disclosure of the study information | 2016/11/01 |
| Last modified on | 2016/10/13 19:54:31 |
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Basic information
Public title
Prospective evaluation of the factors in geriatric assessment for predicting the vulnerability of the elderly patients in out-patient chemotherapy
Acronym
Prospective evaluation of the factors in geriatric assessment for predicting the vulnerability of the elderly patients in out-patient chemotherapy
Scientific Title
Prospective evaluation of the factors in geriatric assessment for predicting the vulnerability of the elderly patients in out-patient chemotherapy
Scientific Title:Acronym
Prospective evaluation of the factors in geriatric assessment for predicting the vulnerability of the elderly patients in out-patient chemotherapy
Region
| Japan |
Condition
Condition
Elderly cancer patients with solid tumors
Classification by specialty
| Medicine in general | Hematology and clinical oncology | Surgery in general |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To prospectively investigate which tools for ADL assessent (MOS-ADL, KPS, G8, or VES-13) could best predict the tolerability of the out-patient chemotherapy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
To investigate which tools for ADL assessent (MOS-ADL, KPS, G8, or VES-13) could best predict the tolerability of the out-patient chemotherapy
Key secondary outcomes
To investigate the tolerability of the chemotherapy regimens selected by physician's subjective evaluation and CGA components independently associated with the tolerability.
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
| 70 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) with 70 years of age or older
(2) with a histologically confirmed diagnosis of cancer at any stage
(3) those planing to continue chemotherapy more than 3 months
(4) those fluent in Japanese
Key exclusion criteria
(1) with disturbance of consciousness
(2) with severe physical impairment
(3) with severe mental disorder
(4) with hematologic malignancy
(4) those considered inappropriate for the participation
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuichi Ando |
Organization
Nagoya University Hospital
Division name
Clinical Oncology and Chemotherapy
Zip code
Address
65 Tsuruma, Showa-ku, Nagoya, Japan
TEL
052-741-1903
yando@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ayumu Matsuoka |
Organization
Nagoya University Hospital
Division name
Clinical Oncology and Chemotherapy
Zip code
Address
65 Tsuruma, Showa-ku, Nagoya, Japan
TEL
052-741-1903
Homepage URL
ayumu0611@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Hospital
Institute
Department
Personal name
Funding Source
Organization
Management Expenses Grants
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 11 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2016 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
(1) Completion of cancer-specific geriatric assessment before the initiation of the out-patient chemotherapy
(2) Measurement of MOS-ADL, KPS, G8, VES-13 and grip strength every month
Management information
Registered date
| 2016 | Year | 10 | Month | 13 | Day |
Last modified on
| 2016 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028080
