Barrett EsophagusBarrettNCT02549053
Prevalence of Human Papillomavirus in Barrett Esophagus Compared With Controls
A study testing esophagus biopsies (pathologic and healthy zones) and esophagus biopsies (healthy zones) in people with Barrett Esophagus, run by University Hospital, Angers at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Barrett Esophagus
- What is being tested?
- esophagus biopsies (pathologic and healthy zones) and esophagus biopsies (healthy zones)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 219 participants
- Where
- 2 sitesFrance
- Study dates
- Feb 2012to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
About this study
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.
Read the 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
- Being tested
- esophagus biopsies (pathologic and healthy zones), esophagus biopsies (healthy zones)
- Medical subject headings
- Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
esophagus biopsies (pathologic and healthy zones)Procedure or surgery
Biopsies were realised in the distal third of esophagus : 4 for Barrett esophagus patients (2 in healthy zone, 2 in pathological zone).
esophagus biopsies (healthy zones)Procedure or surgery
Biopsies were realised in the distal third of esophagus :2 for control patients in healthy zone
| Study group | Role | What they receive |
|---|---|---|
| Barrett esophagus patients | Experimental | esophagus biopsies (pathologic and healthy zones) Receives: Procedure: esophagus biopsies (pathologic and healthy zones) |
| control patients | Sham comparator | esophagus biopsies (healthy zones) Receives: Procedure: esophagus biopsies (healthy zones) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: up to 14 months, time to develop analysis technique at the virology lab, then to collect enough biopsies to start analysis phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2015 (estimated)
- Study startFeb 2012
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Barrett EsophagusStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- François-Xavier Caroli-Bosc, PhD, Principal investigator, UH Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02549053
- Sponsor's protocol ID
- CP 2011-10
- Acronym
- Barrett
- Status last verified
- Sep 2015
- First submitted
- 30 Jul 2015
- Last updated
- 15 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28881904
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Human Papillomavirus in Barrett Esophagus Compared With Controls
- ClinicalTrials.gov ID
- NCT02549053
- Acronym / sponsor ID
- Barrett / CP 2011-10
- Conditions
- Barrett Esophagus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Feb 2012
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 14 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Barrett esophagus patients | Experimental | Procedure: esophagus biopsies (pathologic and healthy zones)esophagus biopsies (pathologic and healthy zones) |
| control patients | Sham comparator | Procedure: esophagus biopsies (healthy zones)esophagus biopsies (healthy zones) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Procedure or surgery | Barrett esophagus patients |
| esophagus biopsies (healthy zones)Biopsies were realised in the distal third of esophagus :2 for control patients in healthy zone | Procedure or surgery | control patients |
Primary outcome
Research of HPV DNA in esophagus biopsies using real time polymerase chain reaction (PCR)
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2015.
- Derived from this study: PubMed 28881904Brochard 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
François-Xavier Caroli-Bosc, PhD principal investigator
UH Angers
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing esophagus biopsies (pathologic and healthy zones) and esophagus biopsies (healthy zones) in people with Barrett Esophagus, run by University Hospital, Angers at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Research of HPV DNA in esophagus biopsies using real time polymerase chain reaction (PCR) (time frame: up to 14 months, time to develop analysis technique at the virology lab, then to collect enough biopsies to start analysis phase). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02549053, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2015.