UMIN-CTR Clinical Trial

Basic information
Public title	Survival risk classification using risk factors for malignant ureteral obstruction patients
Acronym	Risk classification for MUO patients
Scientific Title	Survival risk classification using risk factors for malignant ureteral obstruction patients
Scientific Title:Acronym	Risk classification for MUO patients
Region	Japan

Condition
Condition	Malignant ureteral obstruction
Classification by specialty	Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The appearance of ureteral obstruction caused by metastasis or invasion of malignancy is generally regarded as a sign of poor prognosis. Differences in patient backgrounds may impact clinical outcomes, such as survival time. We plan to study risk facors of survival or stent failure in malignant ureteral obstruction. And we will define risk classification for patient prognosis.
Basic objectives2	Others
Basic objectives -Others	Risk factors
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Overall survival in each risk group
Key secondary outcomes	The relation between stent patency and risk factors

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with malignant ureteral obstruction
Key exclusion criteria	Patients who doctor in charge regarded as ineligible
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Kouji Middle name Last name Izumi
Organization	Kanazawa University
Division name	Graduate school of medical science
Zip code	9208641
Address	13-1 Takaramachi, Kanazawa, Japan
TEL	076-265-2393
Email	azuizu2003@yahoo.co.jp

Public contact
Name of contact person	1st name Kouji Middle name Last name Izumi
Organization	Kanazawa University
Division name	Graduate school of medical science
Zip code	9208641
Address	13-1 Takaramachi, Kanazawa, Japan
TEL	076-265-2393
Homepage URL
Email	azuizu2003@yahoo.co.jp

Sponsor
Institute	Graduate school of medical science, integrative cancer therapy and Urology
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Medical Ethics Committee of Kanazawa University
Address	13-1 Takaramachi, Kanazawa, Japan
Tel	0762652103
Email	rinri@med.kanazawa-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	2013 Year 03 Month 28 Day

Related information
URL releasing protocol	https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_his_list.cgi?recptno=R000012092
Publication of results	Published

Result
URL related to results and publications	https://www.nature.com/articles/s41598-021-84054-7
Number of participants that the trial has enrolled	300
Results	300 patients with 21 different primary sites were enrolled. The numbers of patients in good, intermediate, and poor risk groups were 105, 106, and 89, respectively. Median survival times of patients in good, intermediate, and poor risk groups were 406, 221, and 77 days, respectively (P<0.0001). In 217 patients with ureteral stenting, median ureteral stent failure-free survival times of good, intermediate, and poor risk groups were 385, 183, and 57 days, respectively (P<0.0001).
Results date posted	2021 Year 04 Month 05 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Patients who were diagnosed with malignant neoplasia
Participant flow	All treatments and data collection for MUO were undertaken following written informed consent prior to registration.
Adverse events	None
Outcome measures	The primary endpoint was OS in each PLaCT risk group, whereas the secondary endpoint was stent failure-free survival (SFFS) in ureteral stent-indwelled patients.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2013 Year 02 Month 20 Day
Date of IRB	2013 Year 02 Month 20 Day
Anticipated trial start date	2013 Year 03 Month 28 Day
Last follow-up date	2017 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	To see whether three risk groups classified by risk factors have different survival time.

Management information
Registered date	2013 Year 03 Month 28 Day
Last modified on	2021 Year 04 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012092