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

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ClinicalTrials.gov Identifier: NCT02656576
Recruitment Status : Completed
First Posted : January 15, 2016
Last Update Posted : August 22, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

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

Condition or disease Intervention/treatment Phase
Human Papillomavirus Procedure: Tonsil Biopsy Procedure: Smear Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
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.

Procedure: 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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. rate of concordance for the detection of HPV between biopsy and smear [ Time Frame: 1 month ]
  2. the overall agreement [ Time Frame: 1 month ]
    the overall agreement, assessed by kappa Cohen.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Locations
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France
CHU Toulouse
Toulouse, France
Institut Claudius Regaud
Toulouse, France
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Benjamin VAIREL, Doctor CHU Toulouse

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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT02656576     History of Changes
Other Study ID Numbers: 10 153 02
First Posted: January 15, 2016    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017

Keywords provided by University Hospital, Toulouse:
Human Papillomavirus
oropharynx biopsy
tonsillar lesion