UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013500
Receipt number R000015771
Scientific Title The changes of circulating tumor cells by stereotactic radiotherapy for huge tumor due to telomescan
Date of disclosure of the study information 2014/03/24
Last modified on 2017/03/26 12:31:50

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Basic information

Public title

The changes of circulating tumor cells by stereotactic radiotherapy for huge tumor due to telomescan

Acronym

The measurement of circulating tumor cells due to telomescan

Scientific Title

The changes of circulating tumor cells by stereotactic radiotherapy for huge tumor due to telomescan

Scientific Title:Acronym

The measurement of circulating tumor cells due to telomescan

Region

Japan


Condition

Condition

malignancy

Classification by specialty

Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Efficacy

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Efficacy

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Medicine

Interventions/Control_1

Examination

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 and Female

Key inclusion criteria

Aged over 20
Indication for stereotactic radiotherapy with huge tumor(over 5cm)
Agreement with test of telomescan

Key exclusion criteria

No indication for stereotactic radiotherapy
No agreement with test of telomescan

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kenichi Kashihara

Organization

Tokyo Radiation Oncology Clinic

Division name

radiology

Zip code


Address

3-5-7 Ariake Koto Ward, Tokyo

TEL

03-3529-5420

Email

kashihara@troc.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kenichi Kashihara

Organization

Tokyo Radiation Oncology Clinic

Division name

radiology

Zip code


Address

3-5-7 Ariake Koto Ward, Tokyo

TEL

03-3529-5420

Homepage URL

http://www.troc.jp

Email

info@troc.jp


Sponsor or person

Institute

Tokyo Radiation Oncology Clinic

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

none


Other related organizations

Co-sponsor

none

Name of secondary funder(s)

none


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

東京放射線クリニック(東京都)


Other administrative information

Date of disclosure of the study information

2014 Year 03 Month 24 Day


Related information

URL releasing protocol

http://www.troc.jp

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

Enrolling by invitation

Date of protocol fixation

2014 Year 02 Month 28 Day

Date of IRB


Anticipated trial start date

2014 Year 03 Month 24 Day

Last follow-up date

2015 Year 02 Month 28 Day

Date of closure to data entry

2015 Year 05 Month 31 Day

Date trial data considered complete

2015 Year 05 Month 31 Day

Date analysis concluded

2015 Year 06 Month 30 Day


Other

Other related information



Management information

Registered date

2014 Year 03 Month 24 Day

Last modified on

2017 Year 03 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015771


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name