UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028544 |
|---|---|
| Receipt number | R000032670 |
| Scientific Title | Investigation for the treatment option and cost in urological cancers |
| Date of disclosure of the study information | 2017/08/06 |
| Last modified on | 2022/12/06 12:12:47 |
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Basic information
Public title
Investigation for the treatment option and cost in urological cancers
Acronym
Investigation for the treatment option and cost in urological cancers
Scientific Title
Investigation for the treatment option and cost in urological cancers
Scientific Title:Acronym
Investigation for the treatment option and cost in urological cancers
Region
| Japan |
Condition
Condition
Urological cancers
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigation for the treatment option and cost in urological cancers
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Relationship between the treatment option and medical cost
Key secondary outcomes
Optimal use of medical budget for suitable candidates
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
Urological cancer patients who undergo any therapy
Key exclusion criteria
Urological cancer patients who do not undergo any therapy
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Shingo |
| Middle name | |
| Last name | hatakeyama |
Organization
Hirosaki University
Division name
5 Zaifu-chou
Zip code
036-8562
Address
Hirosaki
TEL
0172395091
uroyone@hirosaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Shingo |
| Middle name | |
| Last name | hatakeyama |
Organization
Hirosaki University School of Medicine
Division name
Urology
Zip code
036-8562
Address
Hirosaki
TEL
0172395091
Homepage URL
uroyone@hirosaki-u.ac.jp
Sponsor or person
Institute
Hirosaki University
Institute
Department
Personal name
Funding Source
Organization
Hirosaki University
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
Hirosaki
Tel
0172395091
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/29796171/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/29796171/
Number of participants that the trial has enrolled
426
Results
A risk score-stratified surveillance protocol has the potential to reduce over investigation during follow-up, making surveillance more cost-effective.
Results date posted
| 2022 | Year | 12 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
To develop a surveillance protocol with improved cost-effectiveness after radical nephroureterectomy (RNU), as the cost-effectiveness of oncological surveillance after RNU remains unclear.
Participant flow
We retrospectively evaluated 426 patients with RNU for upper tract urothelial carcinoma (UTUC) without distant metastasis at 4 hospitals. Patients with routine oncological follow-up were stratified into normal-, high- and very high-risk groups according to a pathology-based protocol utilizing pathological stage, lymphovascular invasion (LVI) and surgical margin (SM). ed to optimize cost-effectiveness.
Adverse events
none
Outcome measures
Cost-effectiveness of the pathology-based protocol was evaluated, and a risk score-based protocol was developed to optimize cost-effectiveness. Risk scores were calculated by summing up risk factors independently associated with recurrence-free survival. Patients were stratified by low-, intermediate- and high-risk score. Estimated cost per recurrence detected by pathology-based and risk score-based protocols was compared.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 30 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 02 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is an observational retrospective study to investigate the relationship between the treatment option and medical cost for urological cancers. Data are obtained from medical chart and estimated medical cost are evaluated and compared among therapeutic selections.
Management information
Registered date
| 2017 | Year | 08 | Month | 05 | 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=R000032670
