UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036596
Receipt No. 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 2019/04/25

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email naoki_terada@med.miyazaki-u.ac.jp

Sponsor
Institute Miyazaki University
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2019 Year 02 Month 04 Day
Date of IRB
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
Date trial data considered complete
Date analysis concluded

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
2019 Year 04 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041692

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.