UMIN-CTR Clinical Trial

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
Email	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
Email	uroyone@hirosaki-u.ac.jp

Sponsor
Institute	Hirosaki University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032670