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

* 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 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

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

Value
https://center6.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