UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028533 |
|---|---|
| Receipt number | R000032653 |
| Scientific Title | An observational validation study of the impact of Frailty on posttreatment adverse events and poor prognosis in patients with a patient with urological diseases |
| Date of disclosure of the study information | 2017/08/06 |
| Last modified on | 2022/12/06 09:07:37 |
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Basic information
Public title
An observational validation study of the impact of Frailty on posttreatment adverse events and poor prognosis in patients with a patient with urological diseases
Acronym
An observational validation study of the impact of Frailty on posttreatment adverse events and poor prognosis in patients with a patient with urological diseases
Scientific Title
An observational validation study of the impact of Frailty on posttreatment adverse events and poor prognosis in patients with a patient with urological diseases
Scientific Title:Acronym
An observational validation study of the impact of Frailty on posttreatment adverse events and poor prognosis in patients with a 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 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
Primary outcomes: Predicting frailty related post-treatment adverse events using Frailty Discriminant score
Secondary outcomes: Comparison of previously reported frailty assessment tools for diagnostic accuracy for frailty, Overall survival, Cancer-specific survival, Postoperative complication, Chemotherapy related to severe adverse events, Clinical indication for definitive therapies (surgery, chemotherapy and/or radiotherapy), Relationship between frailty and quality of life
Key secondary outcomes
This study is a part of our prospective observational study (UMIN000025057). We planned the inter-group difference of frailty among the patients with prostate cancer (PC), renal cell carcinoma (RCC), and urothelial carcinoma (UC) when we successfully developed our CGA tool.
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 | SHINGO |
| Middle name | |
| Last name | Hataeyama |
Organization
Hirosaki University
Division name
Urology
Zip code
036-8562
Address
5 zaifu
TEL
0172395091
shingorilla2@gmail.com
Public contact
Name of contact person
| 1st name | SHINGO |
| Middle name | |
| Last name | Hatakeyama |
Organization
Hirosaki University Graduate School of Medicine
Division name
Urology
Zip code
0368562
Address
5 zaifu
TEL
0172395091
Homepage URL
shingorilla2@gmail.com
Sponsor or person
Institute
Hirosaki University Graduate School of Medicine
Institute
Department
Personal name
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
Hirosaki University School of Medicine
Address
5 Zaifu-chou
Tel
+81172395091
rinri@hirosaki-u.ac.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
| 2017 | Year | 08 | Month | 06 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/31520152/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/31520152/
Number of participants that the trial has enrolled
559
Results
The FDS is a reliable and valid tool for assessing frailty and prognosis in patients with urological cancers.
Results date posted
| 2022 | Year | 12 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We prospectively validate the efficacy of the frailty discriminant score (FDS) in individuals with urological cancers, as there has been growing importance in evaluating frailty in clinical practice.
Participant flow
A prospective, multicenter study was conducted from February 2017 to April 2019. We enrolled 258 patients with urological cancers and 301 community-dwelling participants who were assessed for frailty. Frailty was assessed using FDS that includes ten items, such as physical, mental, and blood biochemical tests.
Adverse events
Outcome measures
The primary outcome was the non-inferiority (margin 5%) of FDS in discriminating patients with urological cancers from controls (Ctrl). The sensitivity, specificity, and area under the receiver operating characteristic (AUROC) curve for each predictive test were calculated. The secondary endpoints included the prediction of overall survival between patients with urological cancer who have high and low FDS. FDS was significantly higher in patients with urological cancers than that in the Ctrl.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 01 | Month | 06 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 02 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 02 | Day |
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 5 years.
Management information
Registered date
| 2017 | Year | 08 | Month | 04 | Day |
Last modified on
| 2022 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032653
