Detection of Human Papillomavirus in Polymerase Chain for Suspicious Lesions of the Amygdala: Concordance Smear-Biopsy (HPV-BIOFRO)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02656576|
Recruitment Status : Completed
First Posted : January 15, 2016
Last Update Posted : August 22, 2017
|Condition or disease||Intervention/treatment||Phase|
|Human Papillomavirus||Procedure: Tonsil Biopsy Procedure: Smear||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Detection of Human Papillomavirus in Polymerase Chain for Suspicious Lesions of the Amygdala: Concordance Smear-Biopsy|
|Actual Study Start Date :||March 2012|
|Actual Primary Completion Date :||May 2017|
|Actual Study Completion Date :||May 2017|
patient with suspected lesions of the tonsillar region
patients will have a tonsil biopsy and a smear
Procedure: Tonsil Biopsy
Biopsies were obtained during endoscopy of Aero-Digestive Tract Superior under general anesthesia.
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.
- 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.
- rate of concordance for the detection of HPV between biopsy and smear [ Time Frame: 1 month ]
- the overall agreement [ Time Frame: 1 month ]the overall agreement, assessed by kappa Cohen.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02656576
|Institut Claudius Regaud|
|Principal Investigator:||Benjamin VAIREL, Doctor||CHU Toulouse|