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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000024395
Receipt No. 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

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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
Email 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
Email ayumu0611@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028080

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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