Clinical Trials Directory

Trials / Completed

CompletedNCT02549053

Prevalence of Human Papillomavirus in Barrett Esophagus Compared With Controls

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
219 (actual)
Sponsor
University Hospital, Angers · Other Government
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREesophagus 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).
PROCEDUREesophagus biopsies (healthy zones)Biopsies were realised in the distal third of esophagus :2 for control patients in healthy zone

Timeline

Start date
2012-02-01
Primary completion
2015-02-01
Completion
2015-02-01
First posted
2015-09-14
Last updated
2015-09-15

Locations

2 sites across 1 country: France

Source: ClinicalTrials.gov record NCT02549053. Inclusion in this directory is not an endorsement.