Japanese National Computed Tomographic (CT) Colonography... | NCT00997802

Studies
Japanese National Computed Tomographic (CT) Colonography Trial

NCT00997802

Sponsor

Japanese CT Colonography Society

Status

Completed

Last Update Posted

Mar 17, 2017Actual

Enrollment

1,257Actual

Phase

Not Applicable

Conditions

Colonic Polyps
Colonic Neoplasms

Interventions

CT colonography and optical colonoscopy

Countries

United States
Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2009

Primary Completion Date

Dec 11, 2015Actual

Completion Date

Jan 2017Actual

First Submitted Date

Oct 18, 2009

First Submission Date that Met QC Criteria

Oct 18, 2009

First Posted Date

Oct 19, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 16, 2017

Last Update Posted Date

Mar 17, 2017Actual

Description Module

Brief Summary

The purpose of this study is to evaluate the sensitivity of computed tomographic colonography (CTC) in detecting colorectal polyps and cancers in 1,500 subjects at increased risk of colorectal cancer (CRC), using optical colonoscopy as the reference standard.

Detailed Description

The investigators will evaluate the sensitivity of CTC in detecting colorectal polyps and cancers (at least 6 mm in diameter) in 1,500 subjects at increased risk of colorectal cancer (CRC), using optical colonoscopy as the reference standard. The primary endpoint will be sensitivity in the detection of colorectal polyps and cancers that are at least 6 mm in diameter. The secondary endpoints will include specificity and predictive values in the detection of colorectal polyps and cancers.

This clinical study will also evaluate the differences of the detection accuracies between human readings with and without computer-aided detection (CAD) that automatically detects colonic lesions in CTC images and presents the detected lesions to the readers. This clinical study will also compare performance between radiologists and gastroenterologists in detecting colorectal lesions in CTC images.

All the CTC images and their interpretations, optical colonoscopy reports and images, and pathology reports of resected colorectal lesion will be prospectively collected from 12 Japanese hospitals participating in the trial. All patients' information will be completely anonymized at each site before any analysis of the data takes place.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,257Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CT colonography and optical colonoscopy	Other		Device: CT colonography and optical colonoscopy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CT colonography and optical colonoscopy	Device	All patients will undergo CT colonography and optical colonoscopy.	CT colonography and optical colonoscopy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
sensitivity in the detection of colorectal polyps and cancers in CTC		1.5 years

Secondary Outcomes

Measure	Description	Time Frame
specificity and predictive values in the detection of colorectal polyps and cancers in CTC.		1.5 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Outpatients who are eligible for optical colonoscopy.
Aged 20 years or older.
Major functions of organs of the subjects are in a good condition.
Signed informed consent forms are obtained from the patients.

Exclusion Criteria:

Known colorectal polyps or cancers at any site at the time of enrollment.
Patients with inflammatory bowel disease.
Fulfillment of clinical criteria for diagnosis of FAP or HNPCC (Amsterdam criteria).
Serious medical conditions that may increase the risk of optical colonoscopy or are so severe that screening would have no benefit.
Previous colorectal surgery.
Gastric or intestinal stenosis, abdominal adhesions, bowel obstruction or perforation, toxic megacolon.
Evidence of an increased risk in carrying out bowel preparation or CTC exams.
Possibility of pregnancy.
Optical colonoscopy or barium enema carried out within the last 3 years.
Patients with psychological conditions that contraindicate colonoscopy or that make them irrelevant to participate in the trial.
Iodine hypersensitivity.
Severe thyroid disease.
Claustrophobia.
Severe deafness.
Subjects whose eligibility for this clinical trial is not appropriate by other reasons.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Koichi Nagata, MD, PhD	Japanese CTC Society	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Japanese CTC Society, 3D imaging Laboratory, Massachusetts General Hospital		Boston	Massachusetts	02114	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27779195	Result	Nagata K, Endo S, Honda T, Yasuda T, Hirayama M, Takahashi S, Kato T, Horita S, Furuya K, Kasai K, Matsumoto H, Kimura Y, Utano K, Sugimoto H, Kato H, Yamada R, Yamamichi J, Shimamoto T, Ryu Y, Matsui O, Kondo H, Doi A, Abe T, Yamano HO, Takeuchi K, Hanai H, Saida Y, Fukuda K, Nappi J, Yoshida H. Accuracy of CT Colonography for Detection of Polypoid and Nonpolypoid Neoplasia by Gastroenterologists and Radiologists: A Nationwide Multicenter Study in Japan. Am J Gastroenterol. 2017 Jan;112(1):163-171. doi: 10.1038/ajg.2016.478. Epub 2016 Oct 25.

ID	Term
D007417	Intestinal Polyps
D011127	Polyps
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D014057	Tomography, X-Ray Computed
D007090	Image Interpretation, Computer-Assisted
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures

ID	Term
D003111	Colonic Polyps
D003110	Colonic Neoplasms