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Prevalence of Human Papillomavirus in Barrett Esophagus Compared With Controls

Prevalence of Human Papillomavirus in Barrett Esophagus Compared With Controls

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02549053
Acronym
Barrett
Enrollment
219
Registered
2015-09-14
Start date
2012-02-29
Completion date
2015-02-28
Last updated
2015-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Barrett Esophagus

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.

Interventions

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

Sponsors

University Hospital, Angers
Lead SponsorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
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 phaseResearch of HPV DNA using real time polymerase chain reaction (PCR)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026