NCT02656576

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

November 2, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 15, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

August 22, 2017

Status Verified

August 1, 2017

Enrollment Period

5.2 years

First QC Date

November 2, 2015

Last Update Submit

August 21, 2017

Conditions

Human Papillomavirus

Keywords

Human Papillomavirusoropharynx biopsytonsillar lesion

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

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

    1 month

  • the overall agreement

    1 month

Study Arms (1)

patient with suspected lesions of the tonsillar region

OTHER

patients will have a tonsil biopsy and a smear

Procedure: Tonsil BiopsyProcedure: Smear

Interventions

Tonsil BiopsyPROCEDURE

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

patient with suspected lesions of the tonsillar region
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.

patient with suspected lesions of the tonsillar region

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU Toulouse

Toulouse, France

Location

Institut Claudius Regaud

Toulouse, France

Location

Study Officials

  • Benjamin VAIREL, Doctor

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2015

First Posted

January 15, 2016

Study Start

March 1, 2012

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

August 22, 2017

Record last verified: 2017-08

Locations

FR(2)