Detection of Human Papillomavirus in Polymerase Chain for Suspicious Lesions of the Amygdala: Concordance Smear-Biopsy
Not Applicable
Completed
- Conditions
- Human Papillomavirus
- Interventions
- Procedure: Tonsil BiopsyProcedure: Smear
- Registration Number
- NCT02656576
- Lead Sponsor
- University Hospital, Toulouse
- Brief Summary
Multicentre prospective study of concordance between two tissue sampling modes (smear / biopsy), which applies the same diagnostic method (PCR).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description patient with suspected lesions of the tonsillar region Smear patients will have a tonsil biopsy and a smear patient with suspected lesions of the tonsillar region Tonsil Biopsy patients will have a tonsil biopsy and a smear
- Primary Outcome Measures
Name Time Method the correlation between the two sampling methods 1 month the correlation between the two sampling methods (smear and biopsy), defined by the probability of positive correlation and the negative concordance probability.
- Secondary Outcome Measures
Name Time Method the overall agreement 1 month the overall agreement, assessed by kappa Cohen.
rate of concordance for the detection of HPV between biopsy and smear 1 month
Trial Locations
- Locations (2)
Institut Claudius Regaud
🇫🇷Toulouse, France
CHU Toulouse
🇫🇷Toulouse, France