Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-02-27 @ 6:49 AM
Study NCT ID:
NCT02373020
Status:
COMPLETED
Last Update Posted:
2015-04-09
First Post:
2015-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Enteropathogenic Escherichia Coli (EPEC): Does it Have a Role in Colorectal Tumourigenesis?
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-07', 'studyFirstSubmitDate': '2015-02-16', 'studyFirstSubmitQcDate': '2015-02-25', 'lastUpdatePostDateStruct': {'date': '2015-04-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-02-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'virulence genes: eaeA, bfpA and stx. PCR', 'timeFrame': '1 week', 'description': 'E. coli colonies isolated from the mucosa of colorectal cancers and from healthy controls were harvested and subjected to DNA extraction (QIAGEN)'}], 'secondaryOutcomes': [{'measure': 'EPEC serogrouping:', 'timeFrame': '1 week', 'description': "Strains biochemically identified as E. coli were selected from the surface of a MacConkey's plate and were serogrouped by slide agglutination tests to detect EPEC using O-specific nonavalent E.coli antiserum (O26, O55, O86, O111, O114, O119, O124, O125, O126, O127, O128, O142), according to the manufacturer's instructions (Bio-Rad)."}, {'measure': 'Strains: OF E COLI', 'timeFrame': '1 week', 'description': 'The specimens were immediately transferred to the lab, inoculated in nutrient broth and vortexed for a few seconds then incubated overnight. The following day the broth culture was subcultured on enteric isolation media. Identification of E. coli was carried out by using standard biochemical methods.'}]}, 'conditionsModule': {'conditions': ['Enteropathogenic Escherichia Coli .', 'Colorectal Carcinoma']}, 'descriptionModule': {'briefSummary': 'Despite the characterization of many aetiologic genetic changes. The specific causative factors in the development of sporadic colorectal cancer remain unclear. This study was performed to detect the possible role of Enteropathogenic Escherichia coli (EPEC) in developing colorectal carcinoma.', 'detailedDescription': "Fresh biopsy specimens have been obtained from the colonic mucosa overlying the colorectal cancer as well as from the colon of the healthy controls. Culture, genotyping and virulence of EPEC were done using (nutrient broth culture, and PCR). Strains biochemically identified as E. coli were selected from the surface of a MacConkey's plate and were serogrouped by slide agglutination tests"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients who were diagnosed to have colorectal cancer (Group 1) and healthy controls who had colonoscopy for colorectal symptoms in the same study period (Group 2', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with colorectal carcinoma after have been diagnosed\n\nExclusion Criteria:\n\n* Patients with inflammatory bowel disease (IBD) or macroscopic signs of inflammation were excluded.'}, 'identificationModule': {'nctId': 'NCT02373020', 'acronym': 'EPEC', 'briefTitle': 'Enteropathogenic Escherichia Coli (EPEC): Does it Have a Role in Colorectal Tumourigenesis?', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'ROLE OF E COLI IN Colorectal Tumourigenesis', 'orgStudyIdInfo': {'id': 'e coli'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'group 1', 'description': 'colonoscopic biopsies from patients with colorectal cancer patients', 'interventionNames': ['Other: colonoscopic biopsies']}, {'label': '(Group 2', 'description': 'colonoscopic biopsies from healthy controls', 'interventionNames': ['Other: colonoscopic biopsies']}], 'interventions': [{'name': 'colonoscopic biopsies', 'type': 'OTHER', 'armGroupLabels': ['(Group 2', 'group 1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Al Mansurah', 'country': 'Egypt', 'facility': 'Mansoura University', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'consultant', 'investigatorFullName': 'MOHAMED ABDELLATIF', 'investigatorAffiliation': 'Mansoura University'}}}}