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


Email



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


Email



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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name