Ignite Creation Date:
2025-12-24 @ 9:39 PM
Ignite Modification Date:
2025-12-29 @ 7:00 PM
Study NCT ID:
NCT04160832
Status:
COMPLETED
Last Update Posted:
2025-01-15
First Post:
2019-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence and Spectrum of Cancer Susceptibility Among Patients with Advanced Colorectal Polyps
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D011127', 'term': 'Polyps'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-13', 'studyFirstSubmitDate': '2019-11-08', 'studyFirstSubmitQcDate': '2019-11-08', 'lastUpdatePostDateStruct': {'date': '2025-01-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of germline pathogenic/likely pathogenic variants in cancer predisposition genes in patients with advanced colorectal polyps', 'timeFrame': '3 years'}], 'secondaryOutcomes': [{'measure': 'Risk factors for germline pathogenic/likely pathogenic variants in patients with advanced colorectal polyps', 'timeFrame': '3 years'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['genetics', 'polyps', 'cancer', 'multi-gene panel'], 'conditions': ['Colorectal Neoplasm']}, 'descriptionModule': {'briefSummary': 'The study is being conducted to determine the prevalence and risk factors for germline cancer susceptibility genetic mutations among patients with advanced colorectal polyps.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Males and females aged 18 - 89, who have been diagnosed with advanced colorectal polyps.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provision to sign and date the consent form\n* Stated willingness to comply with all study procedures and be available for the duration of the study\n* Be a male or female aged 18-89\n* Undergone colonoscopy\n* At least one advanced colorectal polyp, defined as having any of the following:\n* Any polyp ≥ 1cm (adenoma or serrated polyp)\n* Any polyp with villous architecture\n* Any polyp with high-grade dysplasia\n* Sessile serrated polyps with any dysplasia\n* Traditional serrated adenoma\n\nExclusion Criteria:\n\n* Known hereditary cancer syndrome\n* Personal history of inflammatory bowel disease\n* Personal history of colorectal cancer\n* Polyp histology or size unavailable or not documented'}, 'identificationModule': {'nctId': 'NCT04160832', 'briefTitle': 'Prevalence and Spectrum of Cancer Susceptibility Among Patients with Advanced Colorectal Polyps', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Prevalence and Spectrum of Germline Cancer Susceptibility Gene Mutations Among Patients with Advanced Colorectal Polyps', 'orgStudyIdInfo': {'id': '18-2827.cc'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Multi-Cancer Cancer Panel', 'type': 'GENETIC', 'description': 'Eligible patients will receive genetic testing to determine germline cancer predisposition.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Denver', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'overallOfficials': [{'name': 'Swati Patel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}