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

Primary Purpose

Colonic Polyps, Colonic Neoplasms

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
CT colonography and optical colonoscopy
Sponsored by
Japanese CT Colonography Society
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colonic Polyps focused on measuring Computed Tomographic Colonography, Colonic Polyps, Colonic Neoplasms, Computer Aided Diagnosis

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Japanese CTC Society, 3D imaging Laboratory, Massachusetts General Hospital
  • Otarukyokai Hospital
  • Tonan Hospital
  • Hokkaido Social Insurance Hospital
  • Hokkaido Gastroenterology Hospital
  • Kanazawa University Hospital
  • Showa University Northern Yokohama Hospital
  • Kamigoto Hospital
  • Kawasaki Medical School
  • Hamamatsu South Hospital
  • Jichi Medical University Hospital
  • Tokyo Women's Medical University Medical Center East

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

CT colonography and optical colonoscopy

Arm Description

Outcomes

Primary Outcome Measures

sensitivity in the detection of colorectal polyps and cancers in CTC

Secondary Outcome Measures

specificity and predictive values in the detection of colorectal polyps and cancers in CTC.

Full Information

First Posted
October 18, 2009
Last Updated
March 16, 2017
Sponsor
Japanese CT Colonography Society
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1. Study Identification

Unique Protocol Identification Number
NCT00997802
Brief Title
Japanese National Computed Tomographic (CT) Colonography Trial
Acronym
JANCT
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 Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
December 11, 2015 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Japanese CT Colonography Society

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Polyps, Colonic Neoplasms
Keywords
Computed Tomographic Colonography, Colonic Polyps, Colonic Neoplasms, Computer Aided Diagnosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1257 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CT colonography and optical colonoscopy
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
CT colonography and optical colonoscopy
Intervention Description
All patients will undergo CT colonography and optical colonoscopy.
Primary Outcome Measure Information:
Title
sensitivity in the detection of colorectal polyps and cancers in CTC
Time Frame
1.5 years
Secondary Outcome Measure Information:
Title
specificity and predictive values in the detection of colorectal polyps and cancers in CTC.
Time Frame
1.5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Koichi Nagata, MD, PhD
Organizational Affiliation
Japanese CTC Society
Official's Role
Study Director
Facility Information:
Facility Name
Japanese CTC Society, 3D imaging Laboratory, Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Otarukyokai Hospital
City
Otaru
State/Province
Hokkaido
ZIP/Postal Code
047-8510
Country
Japan
Facility Name
Tonan Hospital
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-0001
Country
Japan
Facility Name
Hokkaido Social Insurance Hospital
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
062-8618
Country
Japan
Facility Name
Hokkaido Gastroenterology Hospital
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
065-0041
Country
Japan
Facility Name
Kanazawa University Hospital
City
Kanazawa
State/Province
Ishikawa
ZIP/Postal Code
920-8641
Country
Japan
Facility Name
Showa University Northern Yokohama Hospital
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
224-8503
Country
Japan
Facility Name
Kamigoto Hospital
City
Kamigoto
State/Province
Nagasaki
ZIP/Postal Code
857-4404
Country
Japan
Facility Name
Kawasaki Medical School
City
Kurashiki
State/Province
Okayama
ZIP/Postal Code
701-0192
Country
Japan
Facility Name
Hamamatsu South Hospital
City
Hamamatsu
State/Province
Shizuoka
ZIP/Postal Code
430-0846
Country
Japan
Facility Name
Jichi Medical University Hospital
City
Shimono
State/Province
Tochigi
ZIP/Postal Code
329-0498
Country
Japan
Facility Name
Tokyo Women's Medical University Medical Center East
City
Arakawa-ku
State/Province
Tokyo
ZIP/Postal Code
116-8567
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
27779195
Citation
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.
Results Reference
result
Links:
URL
http://www.nature.com/ajg/journal/v112/n1/full/ajg2016478a.html
Description
Original Contributions

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Japanese National Computed Tomographic (CT) Colonography Trial

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