UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039786 |
|---|---|
| Receipt number | R000045375 |
| Scientific Title | Cohort study on the impact of geriatric assessment on overall survival for urogenital cancer |
| Date of disclosure of the study information | 2020/04/01 |
| Last modified on | 2020/09/19 16:16:24 |
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Basic information
Public title
Geriatric assessment for urogenital cancer
Acronym
Geriatric assessment for urogenital cancer
Scientific Title
Cohort study on the impact of geriatric assessment on overall survival for urogenital cancer
Scientific Title:Acronym
Impact of geriatric assessment on overall survival for urogenital high prevalent tumor (INSIGHT)
Region
| Japan |
Condition
Condition
Urogenital cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
It is not reasonable to recommend invasive treatments for all elderly patients with malignant disease. However, there is no acceptable assessment tools on the appropriate managements for elderly cancer patients with various physical, psychological and socioeconomic conditions. We have carried out invasive treatment such as surgery, radiation therapy and/ or medical treatments for many patients with urogenital cancers in Kurosawa Hospital. In the present cohort study, we investigate impacts of general health, sarcopenia, health-related QOL, socioeconomic status and cognitive function at the baseline and longitudinal changes following interventions on overall survival. If patients want to maintain or improve their physical condition by the professional trainers, we recommend to participate in the medical fitness program in our clinic and assess the longitudinal changes in their physical conditions following physical interventions.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Investigating impacts of clinicopathological features of urogenital cancers and physical status according to multiple geriatric assessments on overall survival.
Key secondary outcomes
1) Investigating impacts of salvage invasive treatments, oncological outcomes and longitudinal changes on physical status according to multiple geriatric assessments on overall survival.
2) Investigating impacts of changes in the physical conditions according to the scheduled multiple geriatric assessments in patients with out without physical interventions on overall survivals.
3) Investigating impacts of changes in the physical conditions from baseline to 1, 2, 3, 5 years following medical interventions on overall survivals.
4) Investigating impacts of all above affecting factors (clinicopathological features and physical conditions) issues on quality adjusted life years (QALY).
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
| 50 | years-old | <= |
Age-upper limit
| 84 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Patients with newly diagnosed urogenital cancer planning invasive medical treatments including surgery, radiation therapy, chemotherapy, hormonal therapy, etc.
2)Planning those above treatments within 3 months after getting informed consent.
3)Aged between 50 and 84 years old
4)Obtain signed informed consent
Key exclusion criteria
1)Having uncontrolled any other cancer
2)Having uncontrolled chronic disease such as diabetes mellitus, hypertension, etc.
3)Having any unacceptable conditions to participate in the present study judged by corresponding physicians
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kazuto |
| Middle name | |
| Last name | Ito |
Organization
Kurosawa Hospital
Division name
Director
Zip code
3701203
Address
187, Yanaka-cho, Takasaki, Gunma, 3701203, Japan
TEL
027-352-1166
kzito@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Emi |
| Middle name | |
| Last name | Kanai |
Organization
Kurosawa Hospital
Division name
Ethic committee
Zip code
3701203
Address
187, Yanaka-cho, Takasaki, Gunma, 3701203, Japan
TEL
027-352-1166
Homepage URL
e_kanai@bishinkai.or.jp
Sponsor or person
Institute
Institute for Preventive Medicine, Kurosawa Hospital
Institute
Department
Personal name
Funding Source
Organization
Institute for Preventive Medicine, Kurosawa Hospital
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
Ethic committee, Kurosawa Hospital
Address
187, Yanaka-cho, Takasaki, Gunma, 3701203, Japan
Tel
027-352-1166
e_kanai@bishinkai.or.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
| 2020 | Year | 04 | 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
| 2020 | Year | 03 | Month | 11 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 27 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2031 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Assessment before registration
1)Signed informed consent
2)Month and year of birth, age
3)past history
4)complication
5)height, weight, BMI
Baseline assessment at the registration (within 2 months after registration and before treatment intervention)
1)Clinicopathological feature of the disease
2)Geriatric assessment
Assessment at 3, 6 months, 1, 2, 3, 5 years after treatment intervention
1) height, weight, BMI
2)treatment effects (CR, PR, SD, PD)
3)additional salvage treatment
4)geriatric assessment
5)physical intervention
Assessment at the end of the fiscal year
Other complications and treatment done for the diseases, survival outcomes
Assessment at the end of the study (March 31, 2030)
1) Other complications and treatment done for the diseases, survival outcomes
2)additional invasive treatment for the corresponding urogenital cancers
Assessment within 1 year after the end of the study
1)Geriatric assessment (G8, ADL, SF-8, assessment for sarcopenia and frail)
Management information
Registered date
| 2020 | Year | 03 | Month | 12 | Day |
Last modified on
| 2020 | Year | 09 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045375
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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