Skip to content

Detection of Human Papillomavirus in Polymerase Chain for Suspicious Lesions of the Amygdala: Concordance Smear-Biopsy

Detection of Human Papillomavirus in Polymerase Chain for Suspicious Lesions of the Amygdala: Concordance Smear-Biopsy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02656576
Acronym
HPV-BIOFRO
Enrollment
80
Registered
2016-01-15
Start date
2012-03-31
Completion date
2017-05-31
Last updated
2017-08-22

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

Conditions

Human Papillomavirus

Keywords

Human Papillomavirus, oropharynx biopsy, tonsillar lesion

Brief summary

Multicentre prospective study of concordance between two tissue sampling modes (smear / biopsy), which applies the same diagnostic method (PCR).

Interventions

PROCEDURETonsil Biopsy

Biopsies were obtained during endoscopy of Aero-Digestive Tract Superior under general anesthesia.

PROCEDURESmear

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.

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

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

Inclusion criteria

* Presents a suspicious lesion of the amygdala region * Have a biopsy of the oropharynx planned in the operating room.

Exclusion criteria

* Pregnant Patient. * Against anesthetic or surgical indication for endoscopy of the upper aerodigestive tract.

Design outcomes

Primary

MeasureTime frameDescription
the correlation between the two sampling methods1 monththe correlation between the two sampling methods (smear and biopsy), defined by the probability of positive correlation and the negative concordance probability.

Secondary

MeasureTime frameDescription
rate of concordance for the detection of HPV between biopsy and smear1 month
the overall agreement1 monththe overall agreement, assessed by kappa Cohen.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026