UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000022013
Receipt No. R000025366
Scientific Title Research concerning Background Factors at Time of Diagnosis and Initial Treatment and Treatment Progress Cancer Patients
Date of disclosure of the study information 2016/04/21
Last modified on 2019/04/23

* 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 Research concerning Background Factors at Time of Diagnosis and Initial Treatment and Treatment Progress Cancer Patients
Acronym J-CaP
(Japan Study Group of Prostate Cancer)
Scientific Title Research concerning Background Factors at Time of Diagnosis and Initial Treatment and Treatment Progress Cancer Patients
Scientific Title:Acronym J-CaP
(Japan Study Group of Prostate Cancer)
Region
Japan

Condition
Condition Prostate cancer
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 A histopathological diagnosis of prostate cancer undergoing treatment in various forms
Basic objectives2 Others
Basic objectives -Others Compare J-CaP with A-CaP
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Patients background at time of diagnosis of prostate cancer, treatment progress and prognosis
Key secondary outcomes Survey of patient QOL during treatment , comparison with A-Cap data and comparison with data in the United and Australia

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
Key inclusion criteria 1)Patients who have received a histopathological diagnosis of prostate cancer between January 1,2016,and December 31,2018
2)Patients who,having received a diagnosis within the abovementioned period, began initial treatment for prostate cancer(including active surveillance)
3)Patients who are either hospitalized as outpaients
Key exclusion criteria 1)Patients for whom information about the time of diagnosis, including histopathological diagnosis, cannot be acquired
Target sample size 20000

Research contact person
Name of lead principal investigator
1st name Akaza
Middle name
Last name Hideyuki
Organization University Tokyo
Division name Research Center Advanced Science and Technology,
Zip code 153-8904
Address 662 Bldg.4,4-6-1 Komaba, Meguro-ku, Tokyo,Japan
TEL 03-5452-5347
Email no@mail

Public contact
Name of contact person
1st name Tae
Middle name
Last name Nakano
Organization J-CaP Secretariat
Division name J-CaP Secretariat
Zip code 153-8904
Address Office of Hideyuki Akaza 6F Bldg.4,4-6-1 Komaba, Meguro-ku, Tokyo,Japan
TEL 03-5452-5347
Homepage URL
Email Jcap-npo@j-cap.jp

Sponsor
Institute J-CaP
Institute
Department

Funding Source
Organization Astellas Pharma Inc.
Takeda Pharmaceutical Company Limited
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 Asai Fifuka CHiken Shinsa Iinkai
Address Katabiracho, Yokohama Hodogaya-ku, Kanagawa
Tel no
Email no

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
2016 Year 04 Month 21 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 No longer recruiting
Date of protocol fixation
2016 Year 03 Month 18 Day
Date of IRB
2016 Year 03 Month 14 Day
Anticipated trial start date
2016 Year 07 Month 01 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information 10000 over Prostate Cancer patients in Japan between January 2016 and december 2018

Management information
Registered date
2016 Year 04 Month 21 Day
Last modified on
2019 Year 04 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025366

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.