UMIN-CTR Clinical Trial

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
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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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041692