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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000025057
Receipt No. R000028835
Scientific Title An observational study evaluating prevalence of frailty in patients with urological disease
Date of disclosure of the study information 2017/01/31
Last modified on 2019/06/16

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Basic information
Public title An observational study evaluating prevalence of frailty in patients with urological disease
Acronym An observational study evaluating prevalence of frailty in patients with urological disease
Scientific Title An observational study evaluating prevalence of frailty in patients with urological disease
Scientific Title:Acronym An observational study evaluating prevalence of frailty in patients with urological disease
Region
Japan

Condition
Condition Urological diseases
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 This is an observational study evaluating prevalence of frailty in patients with urological disease
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Primary endpoint
Detection of frailty among the patients with urological cancers
Key secondary outcomes Secondary endpoints
Clinical implication of frailty on outcomes including treatment selection, complications, and prognossis.

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
20 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria Males and females, 20 years or older, with urological disease who visit Hirosaki University Hospital.
Key exclusion criteria Have any condition, limitation, or disease that could, in the judgment of the investigator, preclude evaluation of questionnaire or frail measurements.
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shingo Hatakeyama
Organization Hirosaki University Hospital
Division name Dept. of Urology
Zip code
Address 53 Honchou, Hirosaki
TEL 0172-39-5091
Email shingoh@hirosaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shingo Hatakeyama
Organization Hirosaki University Hospital
Division name Dept. of Urology
Zip code
Address 53 Honchou, Hirosaki
TEL 0172-39-5091
Homepage URL
Email shingoh@hirosaki-u.ac.jp

Sponsor
Institute Dept. of Urology, Hirosaki University Hospital
Institute
Department

Funding Source
Organization Dept. of Urology, Hirosaki University Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization JAPAN

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 弘前大学病院(青森県)

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 31 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 Enrolling by invitation
Date of protocol fixation
2016 Year 12 Month 05 Day
Date of IRB
Anticipated trial start date
2017 Year 01 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 This study was performed in accordance with the ethical standards of the Declaration of Helsinki and was approved by the ethics review board of the Hirosaki University School of Medicine. All participants provided written informed consent. Frailty is investigated by G8 screening tool, SF36, CES-D, gait speed, handgrip strength, serum test.

Management information
Registered date
2016 Year 11 Month 29 Day
Last modified on
2019 Year 06 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028835

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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