Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2025-12-30 @ 4:39 AM
Study NCT ID:
NCT03361904
Status:
COMPLETED
Last Update Posted:
2017-12-05
First Post:
2017-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Colonoscopic Adenoma and Advanced Neoplasia Detection Rates According to Age
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003111', 'term': 'Colonic Polyps'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}], 'ancestors': [{'id': 'D007417', 'term': 'Intestinal Polyps'}, {'id': 'D011127', 'term': 'Polyps'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6027}, 'targetDuration': '7 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2016-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-01', 'studyFirstSubmitDate': '2017-11-28', 'studyFirstSubmitQcDate': '2017-12-01', 'lastUpdatePostDateStruct': {'date': '2017-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adenoma detection rate according to age', 'timeFrame': 'during colonoscopy', 'description': 'ADR \\<30yo, in 30-34 yo, in 35-39yo, in 40-44yo, in 45-49yo, in 50-54yo, in 55-59yo, in 60-64yo, in 65-69 yo, in 70-74yo, in 75-79yo and \\>79yo intervals'}, {'measure': 'Advanced Neoplasia Detection rate according to age', 'timeFrame': 'during colonoscopy', 'description': 'ANDR \\<30yo, in 30-34 yo, in 35-39yo, in 40-44yo, in 45-49yo, in 50-54yo, in 55-59yo, in 60-64yo, in 65-69 yo, in 70-74yo, in 75-79yo and \\>79yo intervals'}], 'secondaryOutcomes': [{'measure': 'Age', 'timeFrame': 'during colonoscopy', 'description': 'years old'}, {'measure': 'Gender', 'timeFrame': 'during colonoscopy', 'description': 'Male or Female'}, {'measure': 'Indication for colonoscopy', 'timeFrame': 'during colonoscopy', 'description': 'pain / screening/ familial or personal history of polyp or cancer'}, {'measure': 'quality of the preparation', 'timeFrame': 'during colonoscopy', 'description': 'Boston Bowel Preparation Scale Segment Score Description 0: unprepared colon segment with mucosa not senn due to solid stool that cannot be cleared\n\n1. Portion of mucosa of the colon segment seen, but other areas of the colon segment are not well seen due to staining, residual stool, and/or opaque liquid\n2. minor amount of residual staining, small fragments of stool, and/or opaque liquid, but mucosa of colon segments is seen well\n3. entire mucosa of colon segment seen well, with no residual staining, small fragments of stool or opaque liquid\n\nTotal score is a summation of scores from three segments of the colon Score is from 0 to 9'}, {'measure': 'Caecal intubation', 'timeFrame': 'during colonoscopy', 'description': 'Y/N'}, {'measure': 'Withdrawal time', 'timeFrame': 'during colonoscopy', 'description': 'in seconds'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colonic Polyp', 'Colon Adenoma', 'Colonoscopy', 'Colon Cancer', 'Age']}, 'descriptionModule': {'briefSummary': 'Current recommendations for colonoscopy screening programs usually involve patients older than 50 years of age. However, little is known about polyp or adenoma detection rates under 50. We compared these detection rates according to age in a large series of patients in common practice.\n\nMethods: All colonoscopies performed in 2016 in our unit were prospectively recorded. We determined adenoma detection rate (ADR), polyp detection rate (PDR), mean number of polyps (MNP), and advanced neoplasia detection rate (ANDR).', 'detailedDescription': 'Patients All consecutive patients who were scheduled for colonoscopy were included. Exclusion criteria were: patients scheduled for partial colonoscopy, interventional colonoscopy (for stent insertion, stenosis dilation).\n\nData collection The following data have been prospectively collected: age, gender, indication for colonoscopy, preparation procedure and quality of the preparation (assessed by the Boston Bowel Preparation Scale; BBPS) \\[19-20\\], caecal intubation (yes/no), withdrawal time, number and size of polyps and polyp histopathology.\n\nAll clinical data were collected during the procedure by a nurse and an endoscopist on a dedicated software. The database was then supplemented by the Clinical Research Associate for histopathological data.\n\nWe determined adenoma detection rate (ADR; percentage of colonoscopies with at least one adenoma), polyp detection rate (PDR: percentage of colonoscopies with at least one polyp), mean number of polyps per colonoscopy (MNP), large polyp detection rate (LPDR; percentage of colonoscopies with at least one polyp of 1 cm or more) and advanced neoplasia detection rate (ANDR: percentage of colonoscopies with at least one advanced neoplastic lesion as defined below).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'During the study period, 6335 colorectal endoscopic procedures were realized in the endoscopy unit. We excluded 278 sigmoidoscopies and 30 interventional procedures for stent insertion or stenosis dilation. Only diagnostic colonoscopies were recorded, performed in 3308 women (54.9%) and 2719 men (45.1%) with a median age of 57 (range, 15-96: IQR 18).', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All consecutive patients who were scheduled for colonoscopy were included.\n\nExclusion Criteria:\n\n* patients scheduled for partial colonoscopy, interventional colonoscopy (for stent insertion, stenosis dilation).'}, 'identificationModule': {'nctId': 'NCT03361904', 'briefTitle': 'Colonoscopic Adenoma and Advanced Neoplasia Detection Rates According to Age', 'organization': {'class': 'OTHER', 'fullName': "Société Française d'Endoscopie Digestive"}, 'officialTitle': 'Adenoma and Advanced Neoplasia Detection Rates Increase From 45 Year of Age: Results of a Monocentric One-year Observational Cohort Study on 6027 Colonoscopies', 'orgStudyIdInfo': {'id': '2016-ADR according to age'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Colonoscopy', 'type': 'PROCEDURE', 'description': 'Total colonoscopy : All consecutive patients who were scheduled for colonoscopy were included. Exclusion criteria were: patients scheduled for partial colonoscopy, interventional colonoscopy (for stent insertion, stenosis dilation).'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'David Karsenti, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pole Digestif Paris-Bercy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Société Française d'Endoscopie Digestive", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'KARSENTI', 'investigatorAffiliation': "Société Française d'Endoscopie Digestive"}}}}