Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:44 PM
Study NCT ID:
NCT00204867
Status:
COMPLETED
Last Update Posted:
2016-06-20
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Virtual Colonoscopy (VC) for Primary Colorectal Screening
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011127', 'term': 'Polyps'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 272}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-17', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2016-06-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The growth rate (natural history) of small colorectal polyps', 'timeFrame': 'The outcome measure of polyp growth rate is established at the time of surveillance CTC by comparing to the baseline CTC', 'description': 'Polyp growth rates are established by comparing polyp volume at the initial and surveillance CTC studies'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['colorectal', 'polyps'], 'conditions': ['Colorectal Polyps']}, 'referencesModule': {'references': [{'pmid': '23746988', 'type': 'DERIVED', 'citation': 'Pickhardt PJ, Kim DH, Pooler BD, Hinshaw JL, Barlow D, Jensen D, Reichelderfer M, Cash BD. Assessment of volumetric growth rates of small colorectal polyps with CT colonography: a longitudinal study of natural history. Lancet Oncol. 2013 Jul;14(8):711-20. doi: 10.1016/S1470-2045(13)70216-X. Epub 2013 Jun 7.'}]}, 'descriptionModule': {'briefSummary': 'This study involves a primary VC screening for colorectal polyps. The research hypothesis is that VC screening, including surveillance of sub-cm polyps, is a safe and effective approach.', 'detailedDescription': "The purpose of this study is to use virtual colonoscopy screening to learn more about what happens to small colon polyps (less than 10 mm) over time. From this, we can find out whether it's safer to remove all colon polyps right away or leave the small ones in place and remove only those that grow to 10 mm or more."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Screening population for colorectal cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Medium-sized colorectal polyps (6-9 mm)\n\nExclusion Criteria:\n\n* No medium-sized colorectal polyps (6-9 mm)'}, 'identificationModule': {'nctId': 'NCT00204867', 'briefTitle': 'Virtual Colonoscopy (VC) for Primary Colorectal Screening', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'CT Virtual Colonoscopy for Primary Colorectal Screening', 'orgStudyIdInfo': {'id': '2004-0104'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'A', 'description': 'In vivo surveillance of 6-9 mm polyps detected at CTC', 'interventionNames': ['Other: CTC surveillance']}], 'interventions': [{'name': 'CTC surveillance', 'type': 'OTHER', 'description': 'In vivo CTC surveillance of 6-9 mm polyp', 'armGroupLabels': ['A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Perry J. Pickhardt, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin, Madison'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Naval Medical Center', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}