Prevalence of Human Papillomavirus in Barrett Esophagus Compared With Controls

Not Applicable

Completed

• Conditions: Barrett Esophagus
• Interventions: Procedure: esophagus biopsies (pathologic and healthy zones); Procedure: esophagus biopsies (healthy zones)

• Registration Number: NCT02549053
• Lead Sponsor: University Hospital, Angers

Brief Summary

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.

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 Timeline

• Study Start: 2012-02
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Study First Submitted: 2015-07-30
• Status Verified: 2015-09
• Study First Submitted QC: 2015-09-11
• Study First Posted: 2015-09-14
• Last Update Submitted: 2015-09-14
• Last Update Posted: 2015-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 219

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Barrett esophagus patients	esophagus biopsies (pathologic and healthy zones)	esophagus biopsies (pathologic and healthy zones)
control patients	esophagus biopsies (healthy zones)	esophagus biopsies (healthy zones)

Primary Outcome Measures

Name	Time	Method
Research of HPV DNA in esophagus biopsies 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	Research of HPV DNA using real time polymerase chain reaction (PCR)

Trial Locations

Locations (2)

UH Angers; 🇫🇷 Angers, France

UH Nantes; 🇫🇷 Nantes, France