UMIN-CTR Clinical Trial

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
Email	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
Email	e_kanai@bishinkai.or.jp

Sponsor
Institute	Institute for Preventive Medicine, Kurosawa Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000045375