UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021722
Receipt number R000025032
Scientific Title Evaluation of the incidental findings on Computed Tomography in the Emergency Department of Emergency Medical Center
Date of disclosure of the study information 2016/04/01
Last modified on 2016/08/22 10:48:47

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Basic information

Public title

Evaluation of the incidental findings on Computed Tomography in the Emergency Department of Emergency Medical Center

Acronym

Evaluation of the incidental findings on Computed Tomography in the Emergency Department

Scientific Title

Evaluation of the incidental findings on Computed Tomography in the Emergency Department of Emergency Medical Center

Scientific Title:Acronym

Evaluation of the incidental findings on Computed Tomography in the Emergency Department

Region

Japan


Condition

Condition

Emergency Disease

Classification by specialty

Radiology Emergency medicine Intensive care medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We reveal the present situation of incidental findings not relating to emergency treatment plan but needing to additional examination in computed tomography at the emergency department.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The presence and number of incidental findings

Key secondary outcomes

Computed tomography scan parts of incidental findings
Details of incidental findings
Influence in future of incidental findings


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 and Female

Key inclusion criteria

Cases of ambulance transport to and walk in emergency medical center

Key exclusion criteria

Cases of death at emergency department
Cases of no computed tomography
Principal investigator judged inappropriateness cases

Target sample size

15000


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yonemitu Takafumi

Organization

Wakayama Medical University

Division name

Department of Emergency and Critical Care Medicine

Zip code


Address

811-1 Kimiidera, Wakayama 641-8510, Japan

TEL

+81-73-441-0603

Email

mirage10261976@mac.com


Public contact

Name of contact person

1st name
Middle name
Last name Yonemitu Takafumi

Organization

Wakayama Medical University

Division name

Department of Emergency and Critical Care Medicine

Zip code


Address

811-1 Kimiidera, Wakayama 641-8510, Japan

TEL

+81-73-441-0603

Homepage URL


Email

mirage10261976@mac.com


Sponsor or person

Institute

Wakayama Medical University

Institute

Department

Personal name



Funding Source

Organization

Wakayama Medical University

Organization

Division

Category of Funding Organization

Other

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

和歌山県立医科大学付属病院(和歌山県)


Other administrative information

Date of disclosure of the study information

2016 Year 04 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

2016 Year 03 Month 18 Day

Date of IRB


Anticipated trial start date

2016 Year 04 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

We evaluate the present situation of incidental findings not relating to emergency treatment plan but needing to additional examination in computed tomography of emergency department.
The study design is the cohort study.
The way for subscription of object persons is computed tomography of emergency department from April 2013 to March 2016.
The measuring item is the presence of incidental findings not relating to emergency treatment plan but needing to additional examination.


Management information

Registered date

2016 Year 03 Month 31 Day

Last modified on

2016 Year 08 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025032


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name