UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010335 |
|---|---|
| Receipt number | R000012092 |
| Scientific Title | Survival risk classification using risk factors for malignant ureteral obstruction patients |
| Date of disclosure of the study information | 2013/03/28 |
| Last modified on | 2021/04/05 18:51:47 |
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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
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
azuizu2003@yahoo.co.jp
Sponsor or person
Institute
Graduate school of medical science, integrative cancer therapy and Urology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012092
