UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032778
Receipt number R000037393
Scientific Title Clinical application of CT colonography
Date of disclosure of the study information 2020/06/30
Last modified on 2024/03/05 15:23:38

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Basic information

Public title

Clinical application of CT colonography

Acronym

CACTC

Scientific Title

Clinical application of CT colonography

Scientific Title:Acronym

CACTC

Region

Japan


Condition

Condition

Colorectal neoplasms

Classification by specialty

Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Verification of detectability and diagnostic performance for colorectal neoplasms of CT colonography

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Detection rate for colorectal neoplasms and diagnositic accuracy for depth invasion of of CT colonography.

Key secondary outcomes

Percentage of change in treatment policy by CT colonography.


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

40 years-old <=

Age-upper limit

120 years-old >=

Gender

Male and Female

Key inclusion criteria

Over 40 years old.Clinical information including image data of patients whose clinical CT colonography was performed within the period and informed consent was obtained in writing.

Key exclusion criteria

Those for whom the examination could not be completed for any reason, those blow 40 years old or who did not obtain consent in writing.

Target sample size

500


Research contact person

Name of lead principal investigator

1st name Keita
Middle name
Last name Fujimoto

Organization

Gifu University

Division name

Department of Radiogoloy

Zip code

501-1194

Address

Yanagido 1-1,Gifu-shi,Gifu-ken

TEL

058-230-6437

Email

keita.fujimoto.rad@gmail.com


Public contact

Name of contact person

1st name Keita
Middle name
Last name Fujimoto

Organization

Gifu University

Division name

Department of Radiogoloy

Zip code

501-1194

Address

Yanagido 1-1,Gifu-shi,Gifu-ken

TEL

058-230-6437

Homepage URL


Email

keita.fujimoto.rad@gmail.com


Sponsor or person

Institute

Gifu University

Institute

Department

Personal name



Funding Source

Organization

Gifu 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

Gifu university Institutional Review Board

Address

Yanagido 1-1,Gifu-shi,Gifu-ken

Tel

058-230-6000

Email

rinri@gifu-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

2020 Year 06 Month 30 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

Suspended

Date of protocol fixation

2016 Year 04 Month 01 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

Data collection is over and preparation for analysis is in progress.


Management information

Registered date

2018 Year 05 Month 30 Day

Last modified on

2024 Year 03 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037393


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name