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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000009785
Receipt No. R000007913
Scientific Title Analysis of genetic polymorphisms for predicting response to treatment and progression of prostate tumor
Date of disclosure of the study information 2013/02/01
Last modified on 2017/02/14

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Basic information
Public title Analysis of genetic polymorphisms for predicting response to treatment and progression of prostate tumor
Acronym Polymorphisms for Predicting Progression of Prostate tumor (PoPProP trial)
Scientific Title Analysis of genetic polymorphisms for predicting response to treatment and progression of prostate tumor
Scientific Title:Acronym Polymorphisms for Predicting Progression of Prostate tumor (PoPProP trial)
Region
Japan Asia(except Japan) North America
Europe

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

Objectives
Narrative objectives1 Exploratory study of single nucleotide polymorphisms (SNPs) associated with progression of metastatic prostate cancer.
Basic objectives2 Others
Basic objectives -Others To identify single nucleotide polymorphisms which are associated with progression risk and response to drug therapies in advanced (metastatic) prostate cancer.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Significant association between SNPs and cancer-specific survival
Key secondary outcomes Significant association between SNPs and

1. Overall survival
2. Time to castration resistant prostate cancer (CRPC)
3. Time to any death from CRPC
4. Time to cancer death from CRPC

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 1. Prostate cancer patients 20 years old or older
2. Pathologically diagnosed prostate cancer
3. Clinical stage: TanyNanyM1
Key exclusion criteria None
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomonori Habuchi
Organization Akita University Graduate School of Medicine
Division name Department of Urology
Zip code
Address 1-1-1 Hondo, Akita
TEL 018-884-6156
Email tsuchiya@med.akita-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Norihiko Tsuchiya
Organization Yamagata University Faculty of Medicine
Division name Department of Urology
Zip code
Address 2-2-2 Iida-nishi, Yamagata
TEL 023-628-5368
Homepage URL
Email ntsuchiya@med.id.yamagata-u.ac.jp

Sponsor
Institute Department of Urology, Akita University Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of Urology, Akita University Graduate School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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 秋田大学医学部附属病院(秋田県)

Other administrative information
Date of disclosure of the study information
2013 Year 02 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 No longer recruiting
Date of protocol fixation
2012 Year 02 Month 14 Day
Date of IRB
Anticipated trial start date
2012 Year 04 Month 01 Day
Last follow-up date
2019 Year 02 Month 01 Day
Date of closure to data entry
2019 Year 03 Month 01 Day
Date trial data considered complete
2019 Year 06 Month 01 Day
Date analysis concluded
2019 Year 10 Month 01 Day

Other
Other related information Prospective exploratory study

Management information
Registered date
2013 Year 01 Month 15 Day
Last modified on
2017 Year 02 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007913

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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