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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000029563
Receipt No. R000033777
Scientific Title Evaluation of the efficacy of Oncotype DX for prostate cancer
Date of disclosure of the study information 2017/10/16
Last modified on 2017/10/15

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Basic information
Public title Evaluation of the efficacy of Oncotype DX for prostate cancer
Acronym ODX for PC
Scientific Title Evaluation of the efficacy of Oncotype DX for prostate cancer
Scientific Title:Acronym ODX for PC
Region
Japan

Condition
Condition prostate cancer
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To evaluate the efficacy of Oncotype DX for active surveillance of low risk prostate cancer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Oncotype DX in addition to conventional evaluation for low risk prostate cancer correctly predict their prognosis.
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
50 years-old <=
Age-upper limit

Not applicable
Gender Male
Key inclusion criteria 1) over 50 years old men
2) AS (active surveillance) is appropriate
3) Histology (biopsy) prove low risk prostate cancer (T1-2, N0 , M0, Gleason score<=6, PSA<=10 ng/ml)
4) Having provided voluntary written consent for participation in this study
Key exclusion criteria 1) Patients whose laboratory data is not sufficient.
2) Patients judged by investigators ineligible.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoru Maruyama
Organization Hokkaido University Graduate School of Medicine
Division name Department of Genito-Urinary Surgery
Zip code
Address Kita-15, Nishi-7, Kita-ku, Sapporo, Hokkaido 060-8638
TEL 011-706-5966
Email smaru@med.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoru Maruyama
Organization Hokkaido University Graduate School of Medicine
Division name Department of Genito-Urinary Surgery
Zip code
Address Kita-15, Nishi-7, Kita-ku, Sapporo, Hokkaido 060-8638
TEL 011-706-5966
Homepage URL
Email smaru@med.hokudai.ac.jp

Sponsor
Institute Department of Genito-Urinary Surgery, Hokkaido University Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of Genito-Urinary Surgery, Hokkaido University Graduate School of Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Genomic Health, inc.
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 10 Month 16 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
2017 Year 05 Month 31 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information nothing

Management information
Registered date
2017 Year 10 Month 15 Day
Last modified on
2017 Year 10 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033777

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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