Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2026-04-17 @ 4:07 AM
Study NCT ID:
NCT02812550
Status:
COMPLETED
Last Update Posted:
2016-06-24
First Post:
2016-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Full-spectrum Endoscopy in Colorectal Cancer Screening
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 249}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-21', 'studyFirstSubmitDate': '2016-06-15', 'studyFirstSubmitQcDate': '2016-06-21', 'lastUpdatePostDateStruct': {'date': '2016-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'adenoma detection rate in the two different colonoscopies', 'timeFrame': 'one week', 'description': 'number of colonoscopies at wich one or more histologically confirmed adenomas were found divided by the total number of colonoscopies performed in the same time period.'}], 'secondaryOutcomes': [{'measure': 'time to caecal intubation in each group', 'timeFrame': 'one week', 'description': 'time to reach appendicular orifice'}, {'measure': 'total procedure time in each group', 'timeFrame': 'one week', 'description': 'time since the begining of the procedure till is totally finish'}, {'measure': 'Adverse events', 'timeFrame': 'one week', 'description': 'Any inmediatly complication'}, {'measure': 'advance adenoma rate in each group', 'timeFrame': 'one week', 'description': '10mm or greater in size, villous component or high grade dysplasia'}, {'measure': 'polyp detection rate in right and left colon in each group', 'timeFrame': 'one week'}, {'measure': 'polyp retrieval rate in each group', 'timeFrame': 'one week', 'description': 'proportion of resected polyps that were retrieved and sent for histologically analysis'}, {'measure': 'caecal intubation rate in each group', 'timeFrame': 'one week', 'description': 'proportion of all colonoscopic procedures in which the caecum, terminal ileum was reached'}, {'measure': 'colonoscopy withdrawal time', 'timeFrame': 'one week', 'description': 'average time taken withdraw the colonoscope from the caecal pole to the anus.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['full-spectrum endoscopy', 'polyp detection rate', 'colorectal cancer', 'colorectal screening', 'adenoma detection rate', 'endoscopic innovations'], 'conditions': ['Colorectal Cancer']}, 'referencesModule': {'references': [{'pmid': '29283904', 'type': 'DERIVED', 'citation': 'Nunez-Rodriguez H, Diez-Redondo P, Perez-Miranda M, Gonzalez Sagrado M, Conde R, De la Serna C. Role of Full-spectrum Endoscopy in Colorectal Cancer Screening: Randomized Trial. J Clin Gastroenterol. 2019 Mar;53(3):191-196. doi: 10.1097/MCG.0000000000000975.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the adenoma detection rates of full-spectrum endoscopy versus standard forward-viewing colonoscopy in colorectal cancer screening programme.', 'detailedDescription': 'Colorectal cancer is the third most common neoplasia and the second leading cause of cancer death in West countries. Colonoscopy is the gold standard for prevention of colorectal cancer disease. Screening for colorectal cancer with biennial faecal occult blood testing is a widely used strategy followed by colonoscopy for those with a positive test. Colonoscopy identifies polyps during the procedure as well as polyp removal in order to prevent progression to cancer. Although, interval cancer appears after a colonoscopy because of 22-28% of polyp missed rates. Advanced Technology may improve adenoma detection rates so decrease interval cancer and reduce mortally. Full-spectrum endoscopy with 330º angle vision decrease adenoma miss rate in general population.\n\nThe investigators conducted a randomized trial in patients from colorectal cancer screening programme (aged 50-69 years) after faecal immunological test positive. One arm the colonoscopy is performed with standard forward view colonoscopy (170º angle view) and the other arm is performed with full-spectrum endoscopy (EndoChoice) (330º angle view)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient referred for colorectal cancer screening with positive fecal inmunological test.\n* Age between 50 and 69 years\n\nExclusion Criteria:\n\n* history of colonic resection,\n* high risk for colorectal cancer like family history of colorectal cancer o polyposis syndrome,\n* inflammatory bowel disease,\n* patients with lower gastrointestinal bleeding symptoms,\n* acute diverticulitis,\n* colonic strictures,\n* poor bowel preparation (Boston scale less than 5 points)'}, 'identificationModule': {'nctId': 'NCT02812550', 'briefTitle': 'Full-spectrum Endoscopy in Colorectal Cancer Screening', 'organization': {'class': 'OTHER', 'fullName': 'Hospital del Rio Hortega'}, 'officialTitle': 'Impact of Full-spectrum Endoscopy in Colorectal Cancer Screening: Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'GRS 1073/A/15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'full-spectrum colonoscopy', 'description': 'Colonoscopy is performed with a full-spectrum colonoscopy (330º angle of view)', 'interventionNames': ['Procedure: colonoscopy procedure']}, {'type': 'OTHER', 'label': 'standar forward-viewing colonoscopy', 'description': 'Colonoscopy is performed with standar forward-viewing colonoscopy (170º angle of view)', 'interventionNames': ['Procedure: colonoscopy procedure']}], 'interventions': [{'name': 'colonoscopy procedure', 'type': 'PROCEDURE', 'description': 'endoscopy performed with a standard forward view colonoscopy or with full-spectrum endoscopy', 'armGroupLabels': ['full-spectrum colonoscopy', 'standar forward-viewing colonoscopy']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Mª Henar Núñez Rodriguez, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital del Rio Hortega Valladolid, Spain'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital del Rio Hortega', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dra Mª Henar Núñez Rodriguez', 'investigatorFullName': 'Mª Henar Núñez Rodriguez', 'investigatorAffiliation': 'Hospital del Rio Hortega'}}}}