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

Human Papillomavirus Clinical Trial

— HPV-BIOFRO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02656576
• Other study ID #: 10 153 02
• Status: Completed
• Phase: N/A
• First received: November 2, 2015
• Last updated: August 21, 2017
• Start date: March 2012
• Est. completion date: May 2017

Study information

• Verified date: August 2017
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Human Papillomavirus

Intervention

Procedure:
• Tonsil Biopsy
Biopsies were obtained during endoscopy of Aero-Digestive Tract Superior under general anesthesia.
• Smear
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.

Locations

Country	Name	City	State
France	CHU Toulouse	Toulouse
France	Institut Claudius Regaud	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 month
Secondary	rate of concordance for the detection of HPV between biopsy and smear		1 month
Secondary	the overall agreement	the overall agreement, assessed by kappa Cohen.	1 month