UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022852 |
|---|---|
| Receipt number | R000026335 |
| Scientific Title | Investigation of genome-wide SNP analysis and its significance in KYUCOG-1401 (randomized controlled study of GnRH antagonist monotherapy and CAB with GnRH agonist plus bicartamide for patients with metastatic prostate cancer). |
| Date of disclosure of the study information | 2016/06/23 |
| Last modified on | 2023/06/29 09:35:14 |
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Basic information
Public title
Investigation of genome-wide SNP analysis and its significance in KYUCOG-1401 (randomized controlled study of GnRH antagonist monotherapy and CAB with GnRH agonist plus bicartamide for patients with metastatic prostate cancer).
Acronym
KYUCOG-1401 ancillary study (KYUCOG-1401-A)
Scientific Title
Investigation of genome-wide SNP analysis and its significance in KYUCOG-1401 (randomized controlled study of GnRH antagonist monotherapy and CAB with GnRH agonist plus bicartamide for patients with metastatic prostate cancer).
Scientific Title:Acronym
KYUCOG-1401 ancillary study (KYUCOG-1401-A)
Region
| Japan |
Condition
Condition
Metastatic prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To investigate a significance of various SNPs in the hormone therapy for the metastatic prostate cancer by analyzing genome-wide SNP (single-nucleotide polymorphism)
Basic objectives2
Others
Basic objectives -Others
To carry out genome-wide SNP analysis of genome DNA extracted from blood specimen using Japonica array.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Genome-wide SNP analysis using Japonica array.
Key secondary outcomes
Correlation between SNP information and clinical information (subject characteristics, clinical laboratory test, imaging test and endpoints) in KYUCOG-1401.
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) Patients enrolled in KYUCOG-1401 study (UMIN000014243)
(2) Patients with written informed consent.
Key exclusion criteria
(1) Patients in the ethnic group or the race except the Japanese
(2) Any other patients who are regarded as unsuitable for this study by the investigators.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Masatoshi |
| Middle name | |
| Last name | Eto |
Organization
Kyushu University Graduate School of Medicine
Division name
Department of Urology
Zip code
8128582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL
092-642-5603
etom@uro.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Shiota |
Organization
Kyushu University Graduate School of Medicine
Division name
Department of Urology
Zip code
8128582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL
092-642-5603
Homepage URL
shiota@uro.med.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Urology, Kyushu University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Urology, Kyushu 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
(Not for public release)Entered
Address
(Not for public release)Entered
Tel
(Not for public release)Entered
(Not for public release)Entered
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
KYUCOG-1401参加施設
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 06 | Month | 23 | 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
229
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
Completed
Date of protocol fixation
| 2015 | Year | 06 | Month | 02 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 10 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 20 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1.Extraction of DNA from blood specimen.
2. SNP analysis using Japonica array.
3.Individual SNP analysis using PCR method.
4.Statistical analysis of correlation with clinical information.
Management information
Registered date
| 2016 | Year | 06 | Month | 23 | Day |
Last modified on
| 2023 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026335
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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