Prevalence of Human Papillomavirus in Barrett Esophagus Compared With Controls
Barrett
1 other identifier
interventional
219
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2012
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 30, 2015
CompletedFirst Posted
Study publicly available on registry
September 14, 2015
CompletedSeptember 15, 2015
September 1, 2015
3 years
July 30, 2015
September 14, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Research of HPV DNA in esophagus biopsies using real time polymerase chain reaction (PCR)
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
Study Arms (2)
Barrett esophagus patients
EXPERIMENTALesophagus biopsies (pathologic and healthy zones)
control patients
SHAM COMPARATOResophagus biopsies (healthy zones)
Interventions
Biopsies were realised in the distal third of esophagus : 4 for Barrett esophagus patients (2 in healthy zone, 2 in pathological zone).
Biopsies were realised in the distal third of esophagus :2 for control patients in healthy zone
Eligibility Criteria
You may qualify if:
- written consent obtained before gastroscopy,
- patients aged more than 18 years,
You may not qualify if:
- 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,
- curative anticoagulation treatment,
- hemostatic disturbances.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
UH Angers
Angers, 49933, France
UH Nantes
Nantes, France
Related Publications (1)
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.
PMID: 28881904DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
François-Xavier Caroli-Bosc, PhD
UH Angers
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 30, 2015
First Posted
September 14, 2015
Study Start
February 1, 2012
Primary Completion
February 1, 2015
Study Completion
February 1, 2015
Last Updated
September 15, 2015
Record last verified: 2015-09