Prevalence of Human Papillomavirus in Barrett Esophagus Compared With Controls (Barrett)

September 14, 2015 updated by: University Hospital, Angers
The aim of this study was to determine whether the prevalence of Human PapillomaVirus (HPV) was increased in patients with Barrett esophagus compared with controls in a prospective study. Secondary objective was to identify, if present, the type of Human PapillomaVirus (HPV) associated in Barrett esophagus.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Barrett's esophagus (BE) is defined by the replacement of normal stratified squamous epithelium in the distal third of esophagus by specialized intestinal metaplasia. It is related to gastro-esophageal reflux disease. Diagnosis is suspected during endoscopy and confirmed on biopsy. The classification of CM from Prague is validated to describe BE during endoscopy. The main complication of the BE is adenocarcinoma, according to metaplasia-dysplasia-cancer sequence. The incidence of esophageal adenocarcinoma is variable, ranging from 0.4 to 3 %. BE is found in 100% esophageal adenocarcinoma and in 42% junction adenocarcinoma. Among the unknown risk factors involved in the onset of dysplasia, viruses can't be excluded.

It is well established that Human Papillomavirus (HPV) is strongly associated with squamous cell dysplasia of female uterine cervix and its progression to cervical carcinoma. HPV is also implicated in others invasive carcinomas including uterine cervix, vulvar, vaginal, anal, penile, head and neck squamous cell carcinoma. Several studies showed that HPV could be associated in head and neck cancers and that tumor HPV status in patients with oropharyngeal squamous cell carcinomas was an independent prognostic factor for survival. The association between HPV and esophageal squamous cell carcinomas is still controversed with epidemiological studies reporting prevalence of mucosal HPV DNA ranging from 0 to 70%. Studies that have investigated HPV and adenocarcinoma of esophagus or Barrett's esophagus (BE) are scarce and data are not clear. A recent prospective study showed that HPV was strongly associated with Barrett'dysplasia and esophageal adenocarcinoma.

The aim of this study was to determine whether the prevalence of HPV was increased in patients with BE compared with controls in a prospective study. Secondary objective was to identify, if present, the type of HPV associated in BE.

Study Type

Interventional

Enrollment (Actual)

219

Phase

  • Not Applicable

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

  • France
      • Angers, France, 49933
        • UH Angers
      • Nantes, France
        • UH Nantes

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • written consent obtained before gastroscopy,
  • patients aged more than 18 years,
  • normal coagulation parameters Inclusion criteria for group A "control" and B "BE" were as follows, respectively: patients undergoing gastroscopy for non esophageal reason and presented no clinical, endoscopic or histopathological evidence of GERD or complication and patients undergoing gastroscopy for BE surveillance or suspected BE during gastroscopy.

Exclusion Criteria:

  • written consent not obtained before gastroscopy,
  • inability to give informed consent,
  • pregnant or nursing women,
  • major person protected by french law,
  • person who is not affiliated to a social security regime,
  • patient who is in a exclusion period for another clinical study,
  • curative anticoagulation treatment,
  • hemostatic disturbances.

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

  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Barrett esophagus patients
esophagus biopsies (pathologic and healthy zones)
Procedure: esophagus biopsies (pathologic and healthy zones)
Biopsies were realised in the distal third of esophagus : 4 for Barrett esophagus patients (2 in healthy zone, 2 in pathological zone).
Sham Comparator: control patients
esophagus biopsies (healthy zones)
Procedure: esophagus biopsies (healthy zones)
Biopsies were realised in the distal third of esophagus :2 for control patients in healthy zone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Research of HPV DNA in esophagus biopsies using real time polymerase chain reaction (PCR)
Time Frame: up to 14 months, time to develop analysis technique at the virology lab, then to collect enough biopsies to start analysis phase
Research of HPV DNA using real time polymerase chain reaction (PCR)
up to 14 months, time to develop analysis technique at the virology lab, then to collect enough biopsies to start analysis phase

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Investigators

  • Principal Investigator: François-Xavier Caroli-Bosc, PhD, UH Angers

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

February 1, 2012

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

July 30, 2015

First Submitted That Met QC Criteria

September 11, 2015

First Posted (Estimate)

September 14, 2015

Study Record Updates

Last Update Posted (Estimate)

September 15, 2015

Last Update Submitted That Met QC Criteria

September 14, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP 2011-10

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.

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