Prevalence of Human Papillomavirus in Barrett Esophagus Compared With Controls

NCT ID: NCT02549053

Last Updated: 2015-09-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 219 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2015-02-28

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.

Conditions

Barrett Esophagus

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

Barrett esophagus patients

esophagus biopsies (pathologic and healthy zones)

Group Type: EXPERIMENTAL

esophagus biopsies (pathologic and healthy zones)

Intervention Type: PROCEDURE

Biopsies were realised in the distal third of esophagus : 4 for Barrett esophagus patients (2 in healthy zone, 2 in pathological zone).

control patients

esophagus biopsies (healthy zones)

Group Type: SHAM_COMPARATOR

esophagus biopsies (healthy zones)

Intervention Type: PROCEDURE

Biopsies were realised in the distal third of esophagus :2 for control patients in healthy zone

Interventions

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).

Intervention Type: PROCEDURE

esophagus biopsies (healthy zones)

Biopsies were realised in the distal third of esophagus :2 for control patients in healthy zone

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• written consent obtained before gastroscopy,
• patients aged more than 18 years,

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Angers

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

François-Xavier Caroli-Bosc, PhD

Role: PRINCIPAL_INVESTIGATOR

UH Angers

Locations

UH Angers

Angers, , France

UH Nantes

Nantes, , France

Countries

France

References

Brochard C, Ducancelle A, Pivert A, Bodin M, Ricard A, Coron E, Couffon C, Dib N, Luet D, Musquer N, Rhun ML, Bertrais S, Michalak S, Lunel-Fabiani F, Cesbron-Metivier E, Caroli-Bosc FX. Human papillomavirus does not play a role in the Barrett esophagus: a French cohort. Dis Esophagus. 2017 Nov 1;30(11):1-7. doi: 10.1093/dote/dox088.

Reference Type: DERIVED

PMID: 28881904 (View on PubMed)

Other Identifiers

CP 2011-10

Identifier Type: -

Identifier Source: org_study_id