UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057722 |
|---|---|
| Receipt number | R000065955 |
| Scientific Title | Validation study of PLaCT classification for malignant ureteral obstruction in patients treated with metallic stents. |
| Date of disclosure of the study information | 2025/04/25 |
| Last modified on | 2025/04/25 16:47:31 |
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Basic information
Public title
Validation study of PLaCT classification for malignant ureteral obstruction in patients treated with metallic stents.
Acronym
Validation study of PLaCT classification for malignant ureteral obstruction in patients treated with metallic stents.
Scientific Title
Validation study of PLaCT classification for malignant ureteral obstruction in patients treated with metallic stents.
Scientific Title:Acronym
Validation study of PLaCT classification for malignant ureteral obstruction in patients treated with metallic stents.
Region
| Japan |
Condition
Condition
Patients with malignant tumors that have tumor-induced ureteral obstruction
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Patients with malignant tumors who develop ureteral obstruction are generally considered to have a poor prognosis, but due to the diversity of patient backgrounds, including differences in primary site, and the wide range of survival time, it is not clear what factors are associated with life expectancy and stent patency. We conducted a prospective, multicenter study to test whether our prognostic classification could actually work in clinical practice. We scored and classified patients (named PLaCT Risk Classification) according to four factors: type of primary tumor, localization of stenosis (unilateral or bilateral), serum creatinine (Cr) level, and treatment of primary tumor, and found three groups with significantly different stent patency and life expectancy (good group, intermediate group, and poor group), Since the PLaCT classification suggested that the intermediate group was a good indication for metal stents, we used the RUSCH Tumor Ureteral Stent (Teleflex) to determine whether this classification actually reflects metal stent patency and survival. Using the data compiled during the PLaCT classification, we aimed to examine the differences between the PLaCT classification, and the metal stenting cases, as well as to construct a new classification.
Basic objectives2
Others
Basic objectives -Others
Examine the difference in patency between metal stents and conventional polymer stents
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The relationship between each risk factor and ureteral stent patency is examined.
Key secondary outcomes
Survival rates for each risk group are examined.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Installation of a metallic ureteral stent for ureteral obstruction caused by a primary or metastatic tumor in patients with malignant tumors.
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 tumors (pathologically confirmed or diagnosed with a clear clinical course) whose primary or metastatic tumors cause stenosis of the ureter and impaired urinary transit. Any type of malignancy, stage, age, and gender are acceptable.
Key exclusion criteria
Patients with ureteral obstruction other than malignancy
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Taiki |
| Middle name | |
| Last name | Kamijima |
Organization
Kanazawa University Graduate School of Medical Science
Division name
Department of Integrative Cancer Therapy and Urology
Zip code
9208640
Address
13-1 Takaramachi, Kanazawa, Ishikawa 920-8641, Japan
TEL
0762652393
kamiji029@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Taiki |
| Middle name | |
| Last name | Kamijima |
Organization
Kanazawa University Graduate School of Medical Science
Division name
13-1 Takaramachi, Kanazawa, Ishikawa 920-8641, Japan
Zip code
920-8640
Address
13-1 Takaramachi, Kanazawa, Ishikawa 920-8641, Japan
TEL
076-265-2393
Homepage URL
kamiji0029@yahoo.co.jp
Sponsor or person
Institute
Kanazawa University Graduate School of Medical Science
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
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, Ishikawa 920-8641, Japan
Tel
0762652110
rinri@adm.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
金沢大学附属病院
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2019 | Year | 10 | Month | 25 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 25 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 25 | Day |
Last follow-up date
| 2028 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 04 | Month | 25 | Day |
Last modified on
| 2025 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065955
