UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052613 |
|---|---|
| Receipt number | R000060036 |
| Scientific Title | Multi-institutional study to investigate the current status of urological malignancies in Fukushima |
| Date of disclosure of the study information | 2023/11/01 |
| Last modified on | 2023/10/25 18:09:53 |
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Basic information
Public title
Multi-institutional study to investigate the current status of urological malignancies in Fukushima
Acronym
Fukushima Survey of Urinary Tract Malignancies
Scientific Title
Multi-institutional study to investigate the current status of urological malignancies in Fukushima
Scientific Title:Acronym
Fukushima Survey of Urinary Tract Malignancies
Region
| Japan |
Condition
Condition
Urinary Tract Malignancies
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study will be a multi-institutional, observational study that will collect medical information for urinary malignancy from the time of diagnosis to the present and into the future. The collected medical information will be use to generate a large data set including treatment and prognosis for each urinary malignancy to evaluate the efficacy of drug therapy, recurrence-free survival, and progression-free survival.
Basic objectives2
Others
Basic objectives -Others
nothing
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Progression-free survival for each urinary malignancy
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male
Key inclusion criteria
(1) Patients must be 18 years of age or older at the time of initial diagnosis.
2) Patients diagnosed with urologic malignancy based on imaging and pathological diagnosis between October 2008 and October 2028, and undergoing surgical therapy or drug therapy.
(iii) Patients suspected of the presence of urologic malignancy based on diagnostic imaging.
Key exclusion criteria
(1) Patients with other active malignancies (during treatment or within 3 years after treatment)
2) Patients with other comorbidities that make surgical therapy, drug therapy, or histological examination difficult.
(iii) Patients for whom normal follow-up, including imaging tests, is impossible due to other comorbidities or other reasons.
(iv) Other patients deemed inappropriate by the principal investigator or subinvestigators.
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | seiji |
| Middle name | |
| Last name | hoshi |
Organization
Fukushima Medical University
Division name
Urology
Zip code
9601295
Address
1 hikarigaoka fukushima city, fukushima, Japan
TEL
0245471316
uro-hosi@fmu.ac.jp
Public contact
Name of contact person
| 1st name | seiji |
| Middle name | |
| Last name | hoshi |
Organization
Fukushima Medical University
Division name
Urology
Zip code
9601295
Address
1 hikarigaoka fukushima city, fukushima, Japan
TEL
0245471316
Homepage URL
uro-hosi@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
nothing
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
Fukushima Medical University
Address
1 hikarigaoka fukushima city, fukushima, Japan
Tel
0245471825
rs@fmu.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
| 2023 | Year | 11 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 17 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2033 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
nothing
Management information
Registered date
| 2023 | Year | 10 | Month | 25 | Day |
Last modified on
| 2023 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060036
