Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2025-12-25 @ 9:47 PM
Study NCT ID:
NCT05184751
Status:
COMPLETED
Last Update Posted:
2022-01-31
First Post:
2021-12-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Incidence and Risk Factors of Early Onset Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal 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': 'D009369', 'term': 'Neoplasms'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003113', 'term': 'Colonoscopy'}], 'ancestors': [{'id': 'D016099', 'term': 'Endoscopy, Gastrointestinal'}, {'id': 'D016145', 'term': 'Endoscopy, Digestive System'}, {'id': 'D003938', 'term': 'Diagnostic Techniques, Digestive System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18257}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-14', 'studyFirstSubmitDate': '2021-12-22', 'studyFirstSubmitQcDate': '2021-12-22', 'lastUpdatePostDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence of early onset colorectal neoplasias, risk factors', 'timeFrame': '10 years', 'description': 'the real-life incidence of early onset colorectal cancer, advanced neoplasias (colorectal cancer and/or advanced adenoma) and all neoplastic lesions in total in a single non-university endoscopic center, the risk of sex and family history of colorectal cancer'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colorectal Neoplasms']}, 'descriptionModule': {'briefSummary': 'Early onset colorectal cancer (cancer in person younger than 50 years) has increasing incidence last years. The aim of our study was to assess the real-life incidence of early onset colorectal cancer, advanced neoplasias (colorectal cancer and/or advanced adenoma) and all neoplastic lesions in total in a single non-university endoscopic center.', 'detailedDescription': 'The investigators retrospectively assessed the incidence of all neoplastic lesions, advanced neoplasias and colorectal cancer in population under 50 years of age compared to population 50 years and older. The investigators collected the data from all colonoscopic examinations performed in non-university hospital Frydek-Mistek from January 2012 to the end of June 2021.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '97 Years', 'minimumAge': '4 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'all patients who were indicated for colonoscopic examination (all indications) in period january 2012 to the end of june 2021', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: all patient who underwent colonoscopic examination clear indication for colonoscopy\n\nExclusion Criteria: not able to underwent colonoscopy'}, 'identificationModule': {'nctId': 'NCT05184751', 'briefTitle': 'Incidence and Risk Factors of Early Onset Colorectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Frydek-Mistek'}, 'officialTitle': 'Incidence and Risk Factors of Early Onset Colorectal Cancer', 'orgStudyIdInfo': {'id': 'Early onset colorectal cancer'}}, 'armsInterventionsModule': {'armGroups': [{'label': '50 years and over', 'description': 'patients who underwent colonoscopic examination aged 50 years and over', 'interventionNames': ['Other: colonoscopy']}, {'label': 'under 50 years', 'description': 'patients who underwent colonoscopic examination aged under 50 years', 'interventionNames': ['Other: colonoscopy']}], 'interventions': [{'name': 'colonoscopy', 'type': 'OTHER', 'armGroupLabels': ['50 years and over', 'under 50 years']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Ivana Mikoviny Kajzrlikova', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Frydek-Mistek'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Frydek-Mistek', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD, Head of endoscopic department', 'investigatorFullName': 'Ivana Mikoviny Kajzrlikova, MD, PhD', 'investigatorAffiliation': 'Hospital Frydek-Mistek'}}}}