UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009785 |
|---|---|
| Receipt number | 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 21:37:37 |
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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
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
ntsuchiya@med.id.yamagata-u.ac.jp
Sponsor or person
Institute
Department of Urology, Akita University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007913
