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Completed

NCT Number: NCT02656576

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

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

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Key information

Conditions

Human Papillomavirus

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Toulouse, Toulouse, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tonsil Biopsy

Procedure

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

Smear

Procedure

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Acronym: HPV-BIOFRO

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Jan 15, 2016
Registry last updated
Aug 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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