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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Japanese CT Colonography Society.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Hiroyuki Yoshida, Japanese CT Colonography Society
ClinicalTrials.gov Identifier:
NCT00997802
First received: October 18, 2009
Last updated: June 9, 2012
Last verified: June 2012
  Purpose

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 Intervention
Colonic Polyps
Colonic Neoplasms
Device: CT colonography and optical colonoscopy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Japanese CT Colonography Society:

Primary Outcome Measures:
  • sensitivity in the detection of colorectal polyps and cancers in CTC [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • specificity and predictive values in the detection of colorectal polyps and cancers in CTC. [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 1500
Study Start Date: October 2009
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
CT colonography and optical colonoscopy Device: CT colonography and optical colonoscopy
All patients will undergo CT colonography and optical colonoscopy.

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00997802

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

No publications provided

Responsible Party: Hiroyuki Yoshida, 3D Imaging Laboratory, Massachusetts General Hospital, Japanese CT Colonography Society
ClinicalTrials.gov Identifier: NCT00997802     History of Changes
Other Study ID Numbers: UMIN000002097, JANCT-01
Study First Received: October 18, 2009
Last Updated: June 9, 2012
Health Authority: United States: Institutional Review Board
Japan: Institutional Review Board

Keywords provided by Japanese CT Colonography Society:
Computed Tomographic Colonography
Colonic Polyps
Colonic Neoplasms
Computer Aided Diagnosis

Additional relevant MeSH terms:
Colonic Neoplasms
Colonic Polyps
Neoplasms
Colonic Diseases
Colorectal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Intestinal Polyps
Neoplasms by Site
Pathological Conditions, Anatomical
Polyps

ClinicalTrials.gov processed this record on October 21, 2014