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Enteropathogenic Escherichia Coli (EPEC): Does it Have a Role in Colorectal Tumourigenesis? (EPEC)

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ClinicalTrials.gov Identifier: NCT02373020
Recruitment Status : Completed
First Posted : February 26, 2015
Last Update Posted : April 9, 2015
Sponsor:
Information provided by (Responsible Party):
MOHAMED ABDELLATIF, Mansoura University

Brief Summary:
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.

Condition or disease Intervention/treatment
Enteropathogenic Escherichia Coli . Colorectal Carcinoma Other: colonoscopic biopsies

Detailed Description:
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

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Study Type : Observational [Patient Registry]
Actual Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: ROLE OF E COLI IN Colorectal Tumourigenesis
Study Start Date : January 2011
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Group/Cohort Intervention/treatment
group 1
colonoscopic biopsies from patients with colorectal cancer patients
Other: colonoscopic biopsies
(Group 2
colonoscopic biopsies from healthy controls
Other: colonoscopic biopsies



Primary Outcome Measures :
  1. virulence genes: eaeA, bfpA and stx. PCR [ Time Frame: 1 week ]
    E. coli colonies isolated from the mucosa of colorectal cancers and from healthy controls were harvested and subjected to DNA extraction (QIAGEN)


Secondary Outcome Measures :
  1. EPEC serogrouping: [ Time Frame: 1 week ]
    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).

  2. Strains: OF E COLI [ Time Frame: 1 week ]
    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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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
Criteria

Inclusion Criteria:

  • patients with colorectal carcinoma after have been diagnosed

Exclusion Criteria:

  • Patients with inflammatory bowel disease (IBD) or macroscopic signs of inflammation were excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02373020


Locations
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Egypt
Mansoura University
Mansoura, Egypt
Sponsors and Collaborators
Mansoura University
Additional Information:

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Responsible Party: MOHAMED ABDELLATIF, consultant, Mansoura University
ClinicalTrials.gov Identifier: NCT02373020    
Other Study ID Numbers: e coli
First Posted: February 26, 2015    Key Record Dates
Last Update Posted: April 9, 2015
Last Verified: February 2015
Additional relevant MeSH terms:
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Colorectal Neoplasms
Carcinogenesis
Cell Transformation, Neoplastic
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes