Human PapillomavirusHPV-BIOFRONCT02656576
Detection of Human Papillomavirus in Polymerase Chain for Suspicious Lesions of the Amygdala: Concordance Smear-Biopsy
A study testing Tonsil Biopsy and Smear in people with Human Papillomavirus, run by University Hospital, Toulouse at 2 sites in France.
Trial summary
Multicentre prospective study of concordance between two tissue sampling modes (smear / biopsy), which applies the same diagnostic method (PCR). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Human Papillomavirus
- What is being tested?
- Tonsil Biopsy and Smear
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesFrance
- Study dates
- Mar 2012to May 2017
- 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
- Presents a suspicious lesion of the amygdala region
- Have a biopsy of the oropharynx planned in the operating room.
Who cannot join
- Pregnant Patient.
- Against anesthetic or surgical indication for endoscopy of the upper aerodigestive tract.
Trial locations and contacts
2 sites in 1 country.
About this study
Multicentre prospective study of concordance between two tissue sampling modes (smear / biopsy), which applies the same diagnostic method (PCR).
- Conditions
- Human Papillomavirus
- Being tested
- Tonsil Biopsy, Smear
- Keywords
- Human Papillomavirus, oropharynx biopsy, tonsillar lesion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tonsil BiopsyProcedure or surgery
Biopsies were obtained during endoscopy of Aero-Digestive Tract Superior under general anesthesia.
SmearProcedure or surgery
The smears are made in consultation a fortnight before performing endoscopic examination. They are carried out after a local anesthetic spray in order to optimize the number of cells collected.
| Study group | Role | What they receive |
|---|---|---|
| patient with suspected lesions of the tonsillar region | Other | patients will have a tonsil biopsy and a smear Receives: Procedure: Tonsil Biopsy; Procedure: Smear |
What is being measured
The primary outcome is the main question the study is designed to answer.
the correlation between the two sampling methods
the correlation between the two sampling methods (smear and biopsy), defined by the probability of positive correlation and the negative concordance probability.
Measured: 1 month
Secondary outcomes (2)
rate of concordance for the detection of HPV between biopsy and smear
Measured: 1 month
the overall agreement
the overall agreement, assessed by kappa Cohen.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2016 (estimated)
- Study startMar 2012
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human PapillomavirusStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin VAIREL, Doctor, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02656576
- Sponsor's protocol ID
- 10 153 02
- Acronym
- HPV-BIOFRO
- Status last verified
- Aug 2017
- First submitted
- 2 Nov 2015
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Human Papillomavirus in Polymerase Chain for Suspicious Lesions of the Amygdala: Concordance Smear-Biopsy
- ClinicalTrials.gov ID
- NCT02656576
- Acronym / sponsor ID
- HPV-BIOFRO / 10 153 02
- Conditions
- Human Papillomavirus
- Keywords
- Human Papillomavirus, oropharynx biopsy, tonsillar lesion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Mar 2012 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 15 Jan 2016 (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.
Multicentre prospective study of concordance between two tissue sampling modes (smear / biopsy), which applies the same diagnostic method (PCR).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient with suspected lesions of the tonsillar region | Other | Procedure: Tonsil Biopsy, Procedure: Smearpatients will have a tonsil biopsy and a smear |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Presents a suspicious lesion of the amygdala region
- Have a biopsy of the oropharynx planned in the operating room.
Key exclusion criteria (2 listed)
- Pregnant Patient.
- Against anesthetic or surgical indication for endoscopy of the upper aerodigestive tract.
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 |
|---|---|---|
| Tonsil BiopsyBiopsies were obtained during endoscopy of Aero-Digestive Tract Superior under general anesthesia. | Procedure or surgery | patient with suspected lesions of the tonsillar region |
| SmearThe smears are made in consultation a fortnight before performing endoscopic examination. They are carried out after a local anesthetic spray in order to optimize the number of cells collected. | Procedure or surgery | patient with suspected lesions of the tonsillar region |
Primary outcome
the correlation between the two sampling methods
Time frame: 1 month
the correlation between the two sampling methods (smear and biopsy), defined by the probability of positive correlation and the negative concordance probability.
2 secondary outcomes
rate of concordance for the detection of HPV between biopsy and smear
Time frame: 1 month
the overall agreement
Time frame: 1 month
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 22 Aug 2017.
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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.
Benjamin VAIREL, Doctor principal investigator
University Hospital, Toulouse
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tonsil Biopsy and Smear in people with Human Papillomavirus, run by University Hospital, Toulouse 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 2 inclusion and 2 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 22 Aug 2017. 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. 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?
the correlation between the two sampling methods (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Aug 2017; AzTrials last refreshed its copy on 8 Nov 2026.