Ignite Creation Date:
2024-05-05 @ 9:55 PM
Last Modification Date:
2024-10-26 @ 10:11 AM
Study NCT ID:
NCT00997802
Status:
COMPLETED
Last Update Posted:
2017-03-17
First Post:
2009-10-18
Brief Title:
Japanese National Computed Tomographic CT Colonography Trial
Sponsor:
Japanese CT Colonography Society
Organization:
Japanese CT Colonography Society
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
JANCT
Brief Summary:
The purpose of this study is to evaluate the sensitivity of computed tomographic colonography CTC in detecting colorectal polyps and cancers in 1500 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 1500 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None