UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034484
Receipt number R000039322
Scientific Title Comparison of Contrast-Enhanced Ultrasonography with Contrast-Enhanced CT for Diagnosis of Liver Metastases from Colorectal tumor
Date of disclosure of the study information 2018/10/15
Last modified on 2019/04/19 20:36:37

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Basic information

Public title

Comparison of Contrast-Enhanced Ultrasonography with Contrast-Enhanced CT for Diagnosis of Liver Metastases from Colorectal tumor

Acronym

Comparison of Contrast-Enhanced Ultrasonography with Contrast-Enhanced CT for Diagnosis of Liver Metastases from Colorectal tumor

Scientific Title

Comparison of Contrast-Enhanced Ultrasonography with Contrast-Enhanced CT for Diagnosis of Liver Metastases from Colorectal tumor

Scientific Title:Acronym

Comparison of Contrast-Enhanced Ultrasonography with Contrast-Enhanced CT for Diagnosis of Liver Metastases from Colorectal tumor

Region

Japan


Condition

Condition

colorectal tumor

Classification by specialty

Gastroenterology Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the usefulness of comparison of Contrast-Enhanced Ultrasonography with Contrast-Enhanced CT for Diagnosis of Liver Metastases from Colorectal tumor

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Diagnostic performance (sensitivity, specificity, accuracy) for Diagnosis of Liver Metastases from Colorectal tumor using Contrast-Enhanced Ultrasonography

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

20 years-old <=

Age-upper limit

90 years-old >

Gender

Male and Female

Key inclusion criteria

patients with colorectal tumor performed contrast-enhanced CT and contrast-enhanced ultrasonography

Key exclusion criteria

patients who did not obtain consent

Target sample size

280


Research contact person

Name of lead principal investigator

1st name Takeshi
Middle name
Last name Yamamura

Organization

Nagoya university hospital

Division name

Department of Endoscopy

Zip code

4660064

Address

65, Tsurumai-cho, Showa-ku, Nagoya city, Aichi prefecture

TEL

0527412172

Email

tyamamu@med.nagoya-u.ac.jp


Public contact

Name of contact person

1st name Masaya
Middle name
Last name Esaki

Organization

Nagoya university hospital

Division name

Department of Endoscopy

Zip code

4660064

Address

4-3

TEL

0527412172

Homepage URL


Email

em6089@med.nagoya-u.ac.jp


Sponsor or person

Institute

Department of Endoscopy, Nagoya university hospital

Institute

Department

Personal name



Funding Source

Organization

Self funding

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

Nagoya university hospital

Address

65, Tsurumai-cho, Showa-ku, Nagoya city, Aichi prefecture

Tel

0527412172

Email

tyamamu@med.nagoya-u.ac.jp


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

2018 Year 10 Month 15 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

Open public recruiting

Date of protocol fixation

2018 Year 10 Month 01 Day

Date of IRB

2018 Year 12 Month 04 Day

Anticipated trial start date

2018 Year 10 Month 01 Day

Last follow-up date

2021 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Comparison of Contrast-Enhanced Ultrasonography with Contrast-Enhanced CT for Diagnosis of Liver Metastases from Colorectal tumor


Management information

Registered date

2018 Year 10 Month 14 Day

Last modified on

2019 Year 04 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039322


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name