Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2025-12-26 @ 2:23 AM
Study NCT ID:
NCT00997802
Status:
COMPLETED
Last Update Posted:
2017-03-17
First Post:
2009-10-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Japanese National Computed Tomographic (CT) Colonography Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003111', 'term': 'Colonic Polyps'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}], 'ancestors': [{'id': 'D007417', 'term': 'Intestinal Polyps'}, {'id': 'D011127', 'term': 'Polyps'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D023881', 'term': 'Colonography, Computed Tomographic'}], 'ancestors': [{'id': 'D014057', 'term': 'Tomography, X-Ray Computed'}, {'id': 'D007090', 'term': 'Image Interpretation, Computer-Assisted'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011856', 'term': 'Radiographic Image Enhancement'}, {'id': 'D007089', 'term': 'Image Enhancement'}, {'id': 'D010781', 'term': 'Photography'}, {'id': 'D011859', 'term': 'Radiography'}, {'id': 'D014056', 'term': 'Tomography, X-Ray'}, {'id': 'D003938', 'term': 'Diagnostic Techniques, Digestive System'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1257}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-16', 'studyFirstSubmitDate': '2009-10-18', 'studyFirstSubmitQcDate': '2009-10-18', 'lastUpdatePostDateStruct': {'date': '2017-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-10-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'sensitivity in the detection of colorectal polyps and cancers in CTC', 'timeFrame': '1.5 years'}], 'secondaryOutcomes': [{'measure': 'specificity and predictive values in the detection of colorectal polyps and cancers in CTC.', 'timeFrame': '1.5 years'}]}, 'conditionsModule': {'keywords': ['Computed Tomographic Colonography', 'Colonic Polyps', 'Colonic Neoplasms', 'Computer Aided Diagnosis'], 'conditions': ['Colonic Polyps', 'Colonic Neoplasms']}, 'referencesModule': {'references': [{'pmid': '27779195', 'type': 'RESULT', '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.'}], 'seeAlsoLinks': [{'url': 'http://www.nature.com/ajg/journal/v112/n1/full/ajg2016478a.html', 'label': 'Original Contributions'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nThis 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.\n\nAll 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Outpatients who are eligible for optical colonoscopy.\n* Aged 20 years or older.\n* Major functions of organs of the subjects are in a good condition.\n* Signed informed consent forms are obtained from the patients.\n\nExclusion Criteria:\n\n* Known colorectal polyps or cancers at any site at the time of enrollment.\n* Patients with inflammatory bowel disease.\n* Fulfillment of clinical criteria for diagnosis of FAP or HNPCC (Amsterdam criteria).\n* Serious medical conditions that may increase the risk of optical colonoscopy or are so severe that screening would have no benefit.\n* Previous colorectal surgery.\n* Gastric or intestinal stenosis, abdominal adhesions, bowel obstruction or perforation, toxic megacolon.\n* Evidence of an increased risk in carrying out bowel preparation or CTC exams.\n* Possibility of pregnancy.\n* Optical colonoscopy or barium enema carried out within the last 3 years.\n* Patients with psychological conditions that contraindicate colonoscopy or that make them irrelevant to participate in the trial.\n* Iodine hypersensitivity.\n* Severe thyroid disease.\n* Claustrophobia.\n* Severe deafness.\n* Subjects whose eligibility for this clinical trial is not appropriate by other reasons.'}, 'identificationModule': {'nctId': 'NCT00997802', 'acronym': 'JANCT', 'briefTitle': 'Japanese National Computed Tomographic (CT) Colonography Trial', 'organization': {'class': 'OTHER', 'fullName': 'Japanese CT Colonography Society'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'UMIN000002097'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'CT colonography and optical colonoscopy', 'interventionNames': ['Device: CT colonography and optical colonoscopy']}], 'interventions': [{'name': 'CT colonography and optical colonoscopy', 'type': 'DEVICE', 'description': 'All patients will undergo CT colonography and optical colonoscopy.', 'armGroupLabels': ['CT colonography and optical colonoscopy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Japanese CTC Society, 3D imaging Laboratory, Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '047-8510', 'city': 'Otaru', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Otarukyokai Hospital', 'geoPoint': {'lat': 43.18944, 'lon': 141.00222}}, {'zip': '060-0001', 'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Tonan Hospital', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '062-8618', 'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Hokkaido Social Insurance Hospital', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '065-0041', 'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Hokkaido Gastroenterology Hospital', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '920-8641', 'city': 'Kanazawa', 'state': 'Ishikawa-ken', 'country': 'Japan', 'facility': 'Kanazawa University Hospital', 'geoPoint': {'lat': 36.6, 'lon': 136.61667}}, {'zip': '224-8503', 'city': 'Yokohama', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Showa University Northern Yokohama Hospital', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'zip': '857-4404', 'city': 'KamigotÅ', 'state': 'Nagasaki', 'country': 'Japan', 'facility': 'Kamigoto Hospital', 'geoPoint': {'lat': 32.98333, 'lon': 129.08333}}, {'zip': '701-0192', 'city': 'Kurashiki', 'state': 'Okayama-ken', 'country': 'Japan', 'facility': 'Kawasaki Medical School', 'geoPoint': {'lat': 34.58333, 'lon': 133.76667}}, {'zip': '430-0846', 'city': 'Hamamatsu', 'state': 'Shizuoka', 'country': 'Japan', 'facility': 'Hamamatsu South Hospital', 'geoPoint': {'lat': 34.7, 'lon': 137.73333}}, {'zip': '329-0498', 'city': 'Shimono', 'state': 'Tochigi', 'country': 'Japan', 'facility': 'Jichi Medical University Hospital'}, {'zip': '116-8567', 'city': 'Arakawa-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': "Tokyo Women's Medical University Medical Center East"}], 'overallOfficials': [{'name': 'Koichi Nagata, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Japanese CTC Society'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Japanese CT Colonography Society', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': '3D Imaging Laboratory, Massachusetts General Hospital', 'investigatorFullName': 'Hiroyuki Yoshida', 'investigatorAffiliation': 'Japanese CT Colonography Society'}}}}