UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036596 |
|---|---|
| Receipt number | R000041692 |
| Scientific Title | Epidemiological study of trend and efficacy of treatment for urothelial cancer patients using Miyazaki Urological Cancer Database(MUCD) |
| Date of disclosure of the study information | 2019/05/01 |
| Last modified on | 2022/10/26 14:31:24 |
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Basic information
Public title
Epidemiological study of trend and efficacy of treatment for urothelial cancer patients using Miyazaki Urological Cancer Database(MUCD)
Acronym
MUCD urotherial cancer study
Scientific Title
Epidemiological study of trend and efficacy of treatment for urothelial cancer patients using Miyazaki Urological Cancer Database(MUCD)
Scientific Title:Acronym
MUCD urotherial cancer study
Region
| Japan |
Condition
Condition
Urotherial cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Along with the advancement of aging society in Japan, the number of urological cancer patients has increased rapidly. Cancer screening program, such as blood PSA test for prostate cancer, urine cytology for urothelial cancer or renal ultrasonography for renal cancer has been expanding. However, a lot of patients was found in advanced state especially in local regions because of their poor opportunity to see doctors. It is important to recognize the prevalence, treatment and prognosis of these advanced cancer patients.
Recently, a lot of novel treatment modalities including molecular target therapy or immunotherapy for advanced cancer patients. Chemotherapy with cisplatin and gemcitabine has been an standard treatment for advanced urothelial caner. After immune checkpoint inhibitor was approved for the treatment of urothelial cancer, we need to establish a novel standard treatment algorithm. The purpose of our study is to establish a database system of urological cancer in Miyazaki, which can help to elucidate the actual situation at present and sequential changes in the future about the treatment of advanced urotherial cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To understand the clinical characteristics of urothelial cancer patients and to elucidate the trend and the efficacy of treatment for them.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All the patients diagnosed as urotherial cancer for the first time in Miyazaki prefecture from April 2014 to March 2019.
Key exclusion criteria
Patients refused to register in the database.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Toshiyuki |
| Middle name | |
| Last name | Kamoto |
Organization
Miyazaki University Graduate School of Medicine
Division name
Department of Urology
Zip code
889-1692
Address
5200, Kihara, Kiyotake, Miyazaki
TEL
0985-85-2968
tkampro@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Terada |
Organization
Miyazaki University Graduate School of Medicine
Division name
Department of Urology
Zip code
889-1692
Address
5200, Kihara, Kiyotake, Miyazaki
TEL
0985-85-2968
Homepage URL
naoki_terada@med.miyazaki-u.ac.jp
Sponsor or person
Institute
Miyazaki University
Institute
Department
Personal name
Funding Source
Organization
Astra Zeneca
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Miyazaki University Hospital
Address
5200, Kihara, Kiyotake, Miyazaki
Tel
0985-85-2968
miyuki_akino@med.miyazaki-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
| 2019 | Year | 05 | 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
Completed
Date of protocol fixation
| 2019 | Year | 02 | Month | 04 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 27 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 01 | Month | 13 | Day |
Date analysis concluded
| 2021 | Year | 01 | Month | 19 | Day |
Other
Other related information
As most urological cancer patients visit any central hospitals in Miyazaki and rarely move to other prefectures, they can be followed-up easily for a long duration. The real world trend and efficacy of current treatment for urological cancer patients could be elucidated using Miyazaki Urological Cancer Database (MUCD). Thereafter, the unmet needs could be found in the field of treatment for urological cancers in each clinical stage.
Management information
Registered date
| 2019 | Year | 04 | Month | 25 | Day |
Last modified on
| 2022 | Year | 10 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041692
