UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028533
Receipt No. R000032653
Scientific Title An observational prospective validation study of the impact of Frailty Discriminant score on posttreatment adverse events and poor prognosis in patients with patient with urological diseases
Date of disclosure of the study information 2017/08/06
Last modified on 2017/08/05

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title An observational prospective validation study of the impact of Frailty Discriminant score on posttreatment adverse events and poor prognosis in patients with patient with urological diseases
Acronym An observational prospective validation study of the impact of Frailty Discriminant score on posttreatment adverse events and poor prognosis in patients with patient with urological diseases
Scientific Title An observational prospective validation study of the impact of Frailty Discriminant score on posttreatment adverse events and poor prognosis in patients with patient with urological diseases
Scientific Title:Acronym An observational prospective validation study of the impact of Frailty Discriminant score on posttreatment adverse events and poor prognosis in patients with patient with urological diseases
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the validity of Frailty Discriminant score for posttreatment adverse events and poor prognosis in patients with patient with urological diseases in multicenter setting
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Predicting frailty related post-treatment adverse events using Frailty Discriminant score

Key secondary outcomes Comparison of previous reported frailty assessment tools for diagnostic accuracy for frailty
Overall survival
Cancer-specific survival
Postoperative complication
Chemotherapy related severe adverse events
Clinical indication for definitive therapies (surgery, chemotherapy and/or radiotherapy)
Relationship between frailty and quality of life

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 Patients with urological diseases who undergo frailty assessments. Urological diseases include both malignant and non-malignant diseases.
Key exclusion criteria Patients with urological diseases who could not undergo frailty assessments.
Target sample size 600

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shingo Hataeyama
Organization Hirosaki University
Division name Urology
Zip code
Address 5 zaifu
TEL 0172395091
Email shingorilla2@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Shingo Hatakeyama
Organization Hirosaki University Graduate School of Medicine
Division name Urology
Zip code
Address 5 zaifu
TEL 0172395091
Homepage URL
Email shingorilla2@gmail.com

Sponsor
Institute Hirosaki University Graduate School of Medicine
Institute
Department

Funding Source
Organization Hirosaki University Graduate School of Medicine
Organization
Division
Category of Funding Organization Government offices of other countries
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

Other administrative information
Date of disclosure of the study information
2017 Year 08 Month 06 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
2017 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 02 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 is an observational prospective validation study of the impact of Frailty Discriminant score on post-treatment adverse events and poor prognosis in patients with patient with urological diseases in multicenter setting. Patients in this study undergo frailty assessment including G8, gait speed, handgrip strength, fatigue and depression questionnaire, and basic blood biochemical test. Frailty Discriminant score were calculated, and outcomes are prospectively evaluated. Study interval is estimated for 3 years.

Management information
Registered date
2017 Year 08 Month 04 Day
Last modified on
2017 Year 08 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032653

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.