UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006906
Receipt number R000008163
Scientific Title To evaluate intra-fractional prostate motion
Date of disclosure of the study information 2012/01/01
Last modified on 2016/12/22 21:36:08

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

To evaluate intra-fractional prostate motion

Acronym

To evaluate intra-fractional prostate motion

Scientific Title

To evaluate intra-fractional prostate motion

Scientific Title:Acronym

To evaluate intra-fractional prostate motion

Region

Japan


Condition

Condition

Prostate cancer

Classification by specialty

Urology Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate intra-fractional prostate motion

Basic objectives2

Others

Basic objectives -Others

observation study

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

intra-fractional prostate motion

Key secondary outcomes



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


Not applicable

Age-upper limit


Not applicable

Gender

Male

Key inclusion criteria

1 Patients with the prostatatic calcification or a metal marker detect by IGRT system
2 PS = 0 or 1

Key exclusion criteria

1 Patients without the prostatatic calcification and a metal marker detect by IGRT system
2 Treatment posture cannot be held on a bed

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takashi Mizowaki

Organization

Kyoto University Graduate School of Medicine

Division name

Department of Radiation Oncology and Image-applied Therapy

Zip code


Address

54 Shogoinkawahara-cho, Sakyo-Ku, Kyoto

TEL

075-751-3762

Email

mizo@kuhp.kyoto-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takashi Mizowaki

Organization

Kyoto University Graduate School of Medicine

Division name

Department of Radiation Oncology and Image-applied Therapy

Zip code


Address

54 Shogoinkawahara-cho, Sakyo-Ku, Kyoto

TEL

075-751-3762

Homepage URL


Email

mizo@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

Department of Radiation Oncology and Image-applied Therapy, Graduate School of Medicine, Kyoto University

Institute

Department

Personal name



Funding Source

Organization

Department of Radiation Oncology and Image-applied Therapy, Graduate School of Medicine, Kyoto University

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

京都大学病院(京都府)


Other administrative information

Date of disclosure of the study information

2012 Year 01 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

2011 Year 12 Month 19 Day

Date of IRB


Anticipated trial start date

2012 Year 01 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

Evaluate intra-fractional prostate motion by use of calcification or a metal marker within the prostate which can be detected by two orthogonal kv X rays


Management information

Registered date

2011 Year 12 Month 19 Day

Last modified on

2016 Year 12 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008163


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name