Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2026-01-28 @ 7:42 PM
Study NCT ID:
NCT03723720
Status:
COMPLETED
Last Update Posted:
2023-03-02
First Post:
2018-10-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Calculating of Correlations Between ADR, PDR, MAP
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003110', 'term': 'Colonic Neoplasms'}], 'ancestors': [{'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': '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': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6925}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-01', 'studyFirstSubmitDate': '2018-10-26', 'studyFirstSubmitQcDate': '2018-10-26', 'lastUpdatePostDateStruct': {'date': '2023-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'correlation between MAP and ADR for all and screening colonoscopies', 'timeFrame': 'january 2013 - december 2017', 'description': 'Pearson´s correlation coefficient'}, {'measure': 'correlation between MAP and PDR for all and screening colonoscopies', 'timeFrame': 'january 2013 - december 2017', 'description': 'Pearson´s correlation coefficient'}, {'measure': 'correlation between ADR and PDR for all and screening colonoscopies', 'timeFrame': 'january 2013 - december 2017', 'description': 'Pearson´s correlation coefficient'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colon Neoplasm']}, 'descriptionModule': {'briefSummary': 'The aim of our study is to compare MAP (mean adenoma per colonoscopy) with ADR (adenoma detection rate) and PDR (polyp detection rate) of all colonoscopists in our department', 'detailedDescription': 'ADR (adenoma detection rate) is generally accepted quality indicator. For possible gaming with ADR other indicators are needed. MAP (mean adenoma per colonoscopy) reflects the quality of examination of entire colon and is considered to be the most objective quality indicator. The aim of our study is to compare MAP with ADR and PDR (polyp detection rate) of all colonoscopists in our department.\n\nWe want to retrospectively assess the quality indicators of all colonoscopies from January 2013 to December 2017. We want to calculate ADR, PDR and MAP of all our endoscopists for all colonoscopies in patients over 50 years of age excluding therapeutic, IBD, management of complications and sigmoidoscopies (screening, surveillance, diagnostic) and separately only for screening colonoscopies. Correlations between MAP/ADR and MAP/PDR will be performed using Pearson´s correlation coefficient.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'people over 50 years of age coming for colonoscopic examination', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* people over 50 years of age coming for colonoscopic examination (screening, surveillance, diagnostic)\n\nExclusion Criteria:\n\n* age under 50 years\n* indication for colonoscopy: therapeutic, IBD, management of complications and sigmoidoscopies'}, 'identificationModule': {'nctId': 'NCT03723720', 'briefTitle': 'Calculating of Correlations Between ADR, PDR, MAP', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Frydek-Mistek'}, 'officialTitle': 'Calculating of Correlations Between ADR, PDR, MAP', 'orgStudyIdInfo': {'id': 'MAP'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients after colonoscopy over 50 years', 'description': 'All colonoscopies in patients over 50 years of age (screening, surveillance, diagnostic) excluding therapeutic, IBD, management of complications and sigmoidoscopies', 'interventionNames': ['Device: Colonoscopy']}], 'interventions': [{'name': 'Colonoscopy', 'type': 'DEVICE', 'description': 'Endoscopic examination of large bowel', 'armGroupLabels': ['Patients after colonoscopy over 50 years']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Frýdek-Místek', 'country': 'Czechia', 'facility': 'Hospital Frydek-Mistek', 'geoPoint': {'lat': 49.68333, 'lon': 18.35}}], 'overallOfficials': [{'name': 'Ivana Mikoviny Kajzrlikova', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Doctor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'ADR, PDR, MAP of all endoscopists in our unit for both all and screening colonoscopies'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Frydek-Mistek', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Ivana Mikoviny Kajzrlikova, MD, PhD', 'investigatorAffiliation': 'Hospital Frydek-Mistek'}}}}