UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010410 |
|---|---|
| Receipt number | R000012172 |
| Scientific Title | Detection of circulating tumor cells (CTC) with novel viral marker (OBP-401) for patients with prostate cancer |
| Date of disclosure of the study information | 2013/04/04 |
| Last modified on | 2018/01/25 13:22:44 |
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Basic information
Public title
Detection of circulating tumor cells (CTC) with novel viral marker (OBP-401) for patients with prostate cancer
Acronym
Detection of CTC with OBP-401 for prostate cancer
Scientific Title
Detection of circulating tumor cells (CTC) with novel viral marker (OBP-401) for patients with prostate cancer
Scientific Title:Acronym
Detection of CTC with OBP-401 for prostate cancer
Region
| Japan |
Condition
Condition
Prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Purpose of this feasibility study is development of detection system for rare circulating tumor cells in peripheral blood of prostate cancer patients with telomerase-specific replication-adenovirus. The detected CTCs are further analyzed for early detection of prostate cancer and surrogate marker of treatment response.
Basic objectives2
Others
Basic objectives -Others
detection
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Enumeration of circulating tumor cells and its correlation to the other clinical outcomes
Phenotypic analysis of the circulating tumor cells
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 40 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male
Key inclusion criteria
1) Prostate cancer patient
2) Patient who needs routine blood test
3) Needs informed consent
Key exclusion criteria
1) Infection
2) Patients whose physician deems as inadequate
3) refusal
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masato Fujisawa |
Organization
Kobe university graduate school of medicine
Division name
Department of Urology
Zip code
Address
7-5-1, Chuo-ku, Kobe
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kobe university graduate school of medicine
Division name
Department of Urology
Zip code
Address
7-5-1, Kusunoki-cho, Chuo-ku, Kobe
TEL
Homepage URL
Sponsor or person
Institute
Department of Urology, Kobe university graduate school of medicine
Institute
Department
Personal name
Funding Source
Organization
none
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 04 | Month | 04 | 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
| 2013 | Year | 04 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Enumeration of circulating tumor cells and its correlation to the other clinical outcomes
Phenotypic analysis of the circulating tumor cells
Management information
Registered date
| 2013 | Year | 04 | Month | 03 | Day |
Last modified on
| 2018 | Year | 01 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012172
