Enteropathogenic Escherichia Coli .EPECNCT02373020
Enteropathogenic Escherichia Coli (EPEC): Does it Have a Role in Colorectal Tumourigenesis?
An observational study of Enteropathogenic Escherichia Coli . and Colorectal Carcinoma, run by Mansoura University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Enteropathogenic Escherichia Coli ., Colorectal Carcinoma
- What is being tested?
- colonoscopic biopsies
- How many people
- 500 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2011to Mar 2013
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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
Who may be able to join
- patients with colorectal carcinoma after have been diagnosed
Who cannot join
- Patients with inflammatory bowel disease (IBD) or macroscopic signs of inflammation were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- colonoscopic biopsies
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
colonoscopic biopsiesOther
| Study group | Role | What they receive |
|---|---|---|
| group 1 | colonoscopic biopsies from patients with colorectal cancer patients Receives: Other: colonoscopic biopsies | |
| (Group 2 | colonoscopic biopsies from healthy controls Receives: Other: colonoscopic biopsies |
What is being measured
The primary outcome is the main question the study is designed to answer.
virulence genes: eaeA, bfpA and stx. PCR
- coli colonies isolated from the mucosa of colorectal cancers and from healthy controls were harvested and subjected to DNA extraction (QIAGEN)
Measured: 1 week
Secondary outcomes (2)
EPEC serogrouping:
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).
Measured: 1 week
Strains: OF E COLI
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.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2015 (estimated)
- Study startJan 2011
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enteropathogenic Escherichia Coli .Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MOHAMED ABDELLATIF, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02373020
- Sponsor's protocol ID
- e coli
- Acronym
- EPEC
- Status last verified
- Feb 2015
- First submitted
- 16 Feb 2015
- Last updated
- 9 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ROLE OF E COLI IN Colorectal Tumourigenesis
- ClinicalTrials.gov ID
- NCT02373020
- Acronym / sponsor ID
- EPEC / e coli
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 26 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | – | Other: colonoscopic biopsiescolonoscopic biopsies from patients with colorectal cancer patients |
| (Group 2 | – | Other: colonoscopic biopsiescolonoscopic biopsies from healthy controls |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- patients with colorectal carcinoma after have been diagnosed
Key exclusion criteria (1 listed)
- Patients with inflammatory bowel disease (IBD) or macroscopic signs of inflammation were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| colonoscopic biopsies | Other | (Group 2, group 1 |
Primary outcome
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)
2 secondary outcomes
EPEC serogrouping:
Time frame: 1 week
Strains: OF E COLI
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Enteropathogenic Escherichia Coli . and Colorectal Carcinoma, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
virulence genes: eaeA, bfpA and stx. PCR (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2015.