- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02373020
Enteropathogenic Escherichia Coli (EPEC): Does it Have a Role in Colorectal Tumourigenesis? (EPEC)
April 7, 2015 updated by: MOHAMED ABDELLATIF, Mansoura University
ROLE OF E COLI IN Colorectal Tumourigenesis
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.
Study Overview
Status
Completed
Intervention / Treatment
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
Study Type
Observational
Enrollment (Actual)
500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Mansoura, Egypt
- Mansoura University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
group 1
colonoscopic biopsies from patients with colorectal cancer patients
|
|
|
(Group 2
colonoscopic biopsies from healthy controls
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
1 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
1 week
|
|
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.
|
1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2011
Primary Completion (Actual)
March 1, 2013
Study Completion (Actual)
March 1, 2013
Study Registration Dates
First Submitted
February 16, 2015
First Submitted That Met QC Criteria
February 25, 2015
First Posted (Estimate)
February 26, 2015
Study Record Updates
Last Update Posted (Estimate)
April 9, 2015
Last Update Submitted That Met QC Criteria
April 7, 2015
Last Verified
February 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Infections
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Gram-Negative Bacterial Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Intestinal Neoplasms
- Rectal Diseases
- Neoplastic Processes
- Enterobacteriaceae Infections
- Colorectal Neoplasms
- Carcinogenesis
- Escherichia coli Infections
- Cell Transformation, Neoplastic
Other Study ID Numbers
- e coli
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Colorectal Carcinoma
-
National Cancer Institute (NCI)RecruitingStage IV Colorectal Cancer AJCC v8 | Metastatic Microsatellite Stable Colorectal Carcinoma | Refractory Microsatellite Stable Colorectal CarcinomaUnited States
-
Roswell Park Cancer InstituteNational Center for Advancing Translational Sciences (NCATS)RecruitingRecurrent Colorectal Carcinoma | Locally Advanced Colorectal Carcinoma | Stage III Colorectal CancerUnited States
-
National Cancer Institute (NCI)WithdrawnStage IV Colorectal Cancer AJCC v8 | Metastatic Mismatch Repair Proficient Colorectal Carcinoma | Refractory Mismatch Repair Proficient Colorectal CarcinomaUnited States
-
Roswell Park Cancer InstituteWithdrawnPembrolizumab and Autologous Dendritic Cells for the Treatment of Refractory Colorectal Cancer (CRC)Recurrent Colorectal Carcinoma | Stage IV Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Unresectable Colorectal Carcinoma | Metastatic Microsatellite Stable Colorectal CarcinomaUnited States
-
Wuhan Union Hospital, ChinaNot yet recruitingRecurrent Colorectal Carcinoma | Advanced Colorectal CarcinomaChina
-
Academisch Medisch Centrum - Universiteit van Amsterdam...CompletedColorectal Neoplasms | Colorectal Cancer | Colorectal Adenoma | Colorectal Carcinoma | Colorectal Adenoma and CarcinomaNetherlands
-
Emory UniversityBristol-Myers Squibb; National Cancer Institute (NCI); National Institutes of...CompletedColorectal Cancer Metastatic | Colorectal Adenocarcinoma | Stage IV Colorectal Cancer | Stage IVA Colorectal Cancer | Stage IVB Colorectal Cancer | Refractory Colorectal Carcinoma | Metastatic Microsatellite Stable Colorectal Carcinoma | Stage IVC Colorectal CancerUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)Active, not recruitingMetastatic Colorectal Adenocarcinoma | Stage IV Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Metastatic Microsatellite Stable Colorectal Carcinoma | Advanced Microsatellite Stable Colorectal Carcinoma | Advanced Colorectal AdenocarcinomaUnited States
-
ECOG-ACRIN Cancer Research GroupNational Cancer Institute (NCI)RecruitingMetastatic Malignant Neoplasm in the Liver | Metastatic Colorectal Carcinoma | Stage IV Colorectal Cancer AJCC v8 | Unresectable Colorectal CarcinomaUnited States
-
Academic and Community Cancer Research UnitedNational Cancer Institute (NCI)CompletedStage IV Colorectal Cancer AJCC v7 | Stage IVA Colorectal Cancer AJCC v7 | Stage IVB Colorectal Cancer AJCC v7 | Recurrent Colorectal Carcinoma | Metastatic Colorectal Carcinoma | Refractory Colorectal CarcinomaUnited States
Clinical Trials on colonoscopic biopsies
-
University Health Network, TorontoPrincess Margaret Hospital, CanadaCompleted
-
Seoul National University Bundang HospitalCompletedIrritable Bowel Syndrome | Pathophysiology | Tight Junction AlterationKorea, Republic of
-
Peking University Cancer Hospital & InstituteRecruiting
-
Hospital Universitari Vall d'Hebron Research InstituteUnknownLung Transplant RejectionSpain
-
University Hospital, ToulouseNot yet recruiting
-
University of North Carolina, Chapel HillInterpace Diagnostics CorporationCompletedBarretts Esophagus With Dysplasia | Intramucosal AdenocarcinomaUnited States
-
Assistance Publique - Hôpitaux de ParisCompletedCrohn's DiseaseFrance
-
National Taiwan University HospitalCompleted
-
Karolinska InstitutetActive, not recruitingProstate CancerSweden