JANCT: Japanese National Computed Tomographic (CT) Colonography Trial

Sponsor

Japanese CT Colonography Society (Other)

Overall Status

Completed

CT.gov ID

NCT00997802

Collaborator

(none)

1,257

Enrollment

Locations

Arm

Duration (Months)

104.8

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colonic Polyps Colonic Neoplasms	Device: CT colonography and optical colonoscopy	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

1257 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Evaluation of Accuracy of Computed Tomographic Colonography (CTC) in the Diagnosis of Colorectal Tumors by Gastroenterologists and Radiologists With Computer-aided Detection (CAD): A Multicenter Study

Study Start Date :

Oct 1, 2009

Actual Primary Completion Date :

Dec 11, 2015

Actual Study Completion Date :

Jan 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Other: CT colonography and optical colonoscopy	Device: CT colonography and optical colonoscopy All patients will undergo CT colonography and optical colonoscopy.

Arm

Intervention/Treatment

Other: CT colonography and optical colonoscopy

Device: CT colonography and optical colonoscopy

All patients will undergo CT colonography and optical colonoscopy.

Outcome Measures

Primary Outcome Measures

sensitivity in the detection of colorectal polyps and cancers in CTC [1.5 years]

Secondary Outcome Measures

specificity and predictive values in the detection of colorectal polyps and cancers in CTC. [1.5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Japanese CTC Society, 3D imaging Laboratory, Massachusetts General Hospital	Boston	Massachusetts	United States	02114
2	Otarukyokai Hospital	Otaru	Hokkaido	Japan	047-8510
3	Tonan Hospital	Sapporo	Hokkaido	Japan	060-0001
4	Hokkaido Social Insurance Hospital	Sapporo	Hokkaido	Japan	062-8618
5	Hokkaido Gastroenterology Hospital	Sapporo	Hokkaido	Japan	065-0041
6	Kanazawa University Hospital	Kanazawa	Ishikawa	Japan	920-8641
7	Showa University Northern Yokohama Hospital	Yokohama	Kanagawa	Japan	224-8503
8	Kamigoto Hospital	Kamigoto	Nagasaki	Japan	857-4404
9	Kawasaki Medical School	Kurashiki	Okayama	Japan	701-0192
10	Hamamatsu South Hospital	Hamamatsu	Shizuoka	Japan	430-0846
11	Jichi Medical University Hospital	Shimono	Tochigi	Japan	329-0498
12	Tokyo Women's Medical University Medical Center East	Arakawa-ku	Tokyo	Japan	116-8567