UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042742
Receipt number R000048787
Scientific Title Diagnostic Performance of ultra-low dose CT Colonography for the Detection of colorectal Neoplasms.
Date of disclosure of the study information 2020/12/20
Last modified on 2020/12/14 10:41:34

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Basic information

Public title

Diagnostic Performance of ultra-low dose CT Colonography for the Detection of colon polyps.

Acronym

Ultra-low dose CT Colonography for colon polyps.

Scientific Title

Diagnostic Performance of ultra-low dose CT Colonography for the Detection of colorectal Neoplasms.

Scientific Title:Acronym

Ultra-low dose CT Colonography for colorectal Neoplasms.

Region

Japan


Condition

Condition

Colorectal Neoplasms

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the diagnostic accuracy of ultra-low dose CT Colonography for the detection of colorectal neoplasms.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Per-patient performance of CT ultra low dose colonography in the detection of neoplasms, with colonoscopy results as the reference standard.

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

Maneuver

Interventions/Control_1

ultra low dose CT colonography

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

30 years-old <=

Age-upper limit

90 years-old >

Gender

Male and Female

Key inclusion criteria

Individuals who were 30 years of age or older and had abdominal symptoms such as melena or had recent positive immunochemical fecal occult blood test.

Key exclusion criteria

Those who had serious medical conditions which could increase the risk of complications associated with bowel preparation and CT Colonography, and who had colorectal polyps or cancers at any site already known at the time of enrollment, a history of inflammatory bowel disease, lynch syndrome, familial polyposis, colorectal surgery, hyperthyroidism, or iodine contrast medium allergy.

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Takayaki
Middle name
Last name Yasuda

Organization

Nagasaki Kamigoto Hospital

Division name

Radiology

Zip code

857-4404

Address

1549-11, Shinkamigoto, Minamimatsuura, Nagasaki, Japan

TEL

0959-52-3000

Email

kamihp3@air.ocn.ne.jp


Public contact

Name of contact person

1st name Takayaki
Middle name
Last name Yasuda

Organization

Nagasaki Kamigoto Hospital

Division name

Radiology

Zip code

857-4404

Address

1549-11, Shinkamigoto, Minamimatsuura, Nagasaki, Japan

TEL

0959-52-3000

Homepage URL


Email

kamihp3@air.ocn.ne.jp


Sponsor or person

Institute

Nagasaki Kamigoto Hospital

Institute

Department

Personal name



Funding Source

Organization

Nagasaki Kamigoto Hospital

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

Nagasaki Kamigoto Hospital

Address

1549-11, Shinkamigoto, Minamimatsuura, Nagasaki, Japan

Tel

0959-52-3000

Email

kamihp3@air.ocn.ne.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 12 Month 20 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled

200

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

2013 Year 10 Month 01 Day

Date of IRB

2013 Year 10 Month 01 Day

Anticipated trial start date

2014 Year 01 Month 01 Day

Last follow-up date

2021 Year 03 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 12 Month 14 Day

Last modified on

2020 Year 12 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048787


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name