Ignite Creation Date:
2025-12-25 @ 1:15 AM
Ignite Modification Date:
2025-12-25 @ 11:25 PM
Study NCT ID:
NCT00720993
Status:
UNKNOWN
Last Update Posted:
2009-04-23
First Post:
2008-07-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Colorectal Cancer Screening Validation Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Rectal smears ("cytology brush") samples and RNA recovered from such materials.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 165}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2009-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-04-22', 'studyFirstSubmitDate': '2008-07-21', 'studyFirstSubmitQcDate': '2008-07-21', 'lastUpdatePostDateStruct': {'date': '2009-04-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '- To select a threshold for Mahalanobis distance to determine the best operating characteristics (sensitivity and specificity) in subjects with cancer and subjects without cancer. - To explore other empirical metrics based on previous exploratory data', 'timeFrame': 'Mai 2009'}], 'secondaryOutcomes': [{'measure': '- To obtain data to estimate sensitivity, specificity, and the ROC curve for a test based on M-distance. - To determine the variability of sensitivity and specificity estimates', 'timeFrame': 'Mai 2009'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Colorectal cancer screening', 'Gene expression', 'RTPCR'], 'conditions': ['Colorectal Cancer Screening']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the gene expression patterns from colorectal mucosal cells collected through the use of a standard anoscope and cytology brush. Patients will include those scheduled for routine colonoscopy procedures and those with confirmed colorectal cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing routine colonoscopy screening or patients scheduled for colorectal cancer surgery.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* willing to provide informed consent\n* greater than or equal to 50 years of age\n* patient is scheduled for routine colonoscopy procedure or colorectal cancer surgery\n* subject is willing to provide colorectal mucosal sample for gene expression testing\n\nExclusion Criteria:\n\n* recent radiation or treatment for gynecologic, prostate or rectal cancer\n* recent surgery for anal rectal disease\n* polys, family or self history of cancer (control group only)\n* GI disease\n* any mucosal disease or systemic condition that may confound the scientific interpretation of the gene expression results'}, 'identificationModule': {'nctId': 'NCT00720993', 'acronym': 'CRC screening', 'briefTitle': 'Colorectal Cancer Screening Validation Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'IntelliGeneScan, Inc.'}, 'officialTitle': 'Altered Gene Expression in Colorectal "Smears" of Individuals With Colon Cancer', 'orgStudyIdInfo': {'id': 'IGS-08-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Control group - patients scheduled for routine colonoscopy procedures with no self or family history or other GI conditions.'}, {'label': '2', 'description': 'Case group - patients with confirmed colorectal carcinoma scheduled for surgery or observed during routine colonoscopy screening.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IntelliGeneScan, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'BiotechNiks / Molecular Medicine Research Institute', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Lothar Wieczorek, PhD, Clinical and Regulatory Consultant', 'oldOrganization': 'IntelliGeneScan, Inc.'}}}}