UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035120
Receipt number R000040030
Scientific Title Observational study for clinical outcome and quality of life in patients after each treatment for prostate cancer.
Date of disclosure of the study information 2018/12/06
Last modified on 2019/07/04 02:53:18

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Basic information

Public title

Observational study for clinical outcome and quality of life in patients after each treatment for prostate cancer.

Acronym

Clinical outcome and QOL in patients after treatment for prostate cancer

Scientific Title

Observational study for clinical outcome and quality of life in patients after each treatment for prostate cancer.

Scientific Title:Acronym

Clinical outcome and QOL in patients after treatment for prostate cancer

Region

Japan


Condition

Condition

Prostate cancer

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Clinical outcome and QOL after each treatment for prostate cancer

Basic objectives2

Others

Basic objectives -Others

Comparison of clinical outcomes and change of QOL among treatments.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Biochemical failure
Cancer specific survival
Overall survival

Key secondary outcomes

chronological change of QOL after each treatment


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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male

Key inclusion criteria

Diagnosed as prostate cancer by pathological findings
Stage A,B,C and D
more than 20 years old
patients treated for prostate cancer

Key exclusion criteria

patients who cannot answer the questionnaires
patients without informed consent

Target sample size

1250


Research contact person

Name of lead principal investigator

1st name Yasushi
Middle name
Last name Nakai

Organization

Nara Medical University

Division name

Department of Urology

Zip code

634-8522

Address

Kashihara

TEL

0744240345

Email

nakaiyasusiuro@live.jp


Public contact

Name of contact person

1st name Yasushi
Middle name
Last name Nakai

Organization

Nara Medical University

Division name

Department of Urology

Zip code

634-8522

Address

Kashihara

TEL

0744-22-3051

Homepage URL


Email

nakaiyasusiuro@live.jp


Sponsor or person

Institute

Nara Medical University

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

the ethics committee of Nara Medical university

Address

840 Shijyocho Kashihara Nara

Tel

0744-22-3051

Email

ino_rinri@naramed-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

2018 Year 12 Month 06 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

Enrolling by invitation

Date of protocol fixation

2018 Year 12 Month 06 Day

Date of IRB

2018 Year 12 Month 17 Day

Anticipated trial start date

2018 Year 12 Month 06 Day

Last follow-up date

2033 Year 10 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

QOL and clinical outcome


Management information

Registered date

2018 Year 12 Month 03 Day

Last modified on

2019 Year 07 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040030


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name