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

University Hospital, Toulouse80 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Human Papillomavirus

Interventions

Tonsil BiopsyPROCEDURE

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

SmearPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

CHU Toulouse

Toulouse, France

Institut Claudius Regaud

Toulouse, France

Outcomes

Primary Outcomes

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.

Time frame: 1 month

Secondary Outcomes

rate of concordance for the detection of HPV between biopsy and smear

Time frame: 1 month

the overall agreement

the overall agreement, assessed by kappa Cohen.

Time frame: 1 month

Data from ClinicalTrials.gov

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