Japanese National Computed Tomographic (CT) Colonography Trial (JANCT)

March 16, 2017 updated by: Hiroyuki Yoshida, Japanese CT Colonography Society

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1257

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Japanese CT Colonography Society

Investigators

  • Study Director: Koichi Nagata, MD, PhD, Japanese CTC Society

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (ACTUAL)

December 11, 2015

Study Completion (ACTUAL)

January 1, 2017

Study Registration Dates

First Submitted

October 18, 2009

First Submitted That Met QC Criteria

October 18, 2009

First Posted (ESTIMATE)

October 19, 2009

Study Record Updates

Last Update Posted (ACTUAL)

March 17, 2017

Last Update Submitted That Met QC Criteria

March 16, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMIN000002097

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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