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Completed

NCT Number: NCT02604121

Cytological Screening for Early Diagnosis of Precancerous or Cancerous Lesions of Oral Cavity

Prospective study of diagnosis validation of a cytological technique. 200 patients with oral cavity cancerous and precancerous lesions will be enrolled.

A cytological sample of the lesion will be performed by transepithelial brushing ( Orcellex® Rovers brush) in cytology liquid-based technology (methode ThinPrep 2000 (Hologic®)). A microscopic double blind reading will be performed. A biopsy sampling will be carried out in accordance with current strategy of screening. The brushing diagnosis quality will be compared to the biopsy which is the gold standard.

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Key information

Conditions

Mouth Neoplasms Head and Neck Neoplasms Mouth Diseases Neoplasms Neoplasms by Site Stomatognathic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Toulouse

Toulouse, 31059, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • one or several cancerous or pre-cancerous lesions of oral cavity newly diagnosed or detected during a follow-up visit

Exclusion criteria

  • pregnant or lactating women
  • patients under juridical protection

Treatment and study plan

Orcellex® Rovers brush

Device

transepithelial brushing

Primary outcomes

  1. Diagnostic validity of lesion (Bethesda system, 2001)

    Time frame: baseline

    Diagnostic validity (specificity and sensibility, the classification of lesions is performed according Bethesda system, 2001 and the reference is the histology of biopsy of lesion

Secondary outcomes

  1. Diagnostic validity - predictive value (positive and negative)

    Time frame: baseline

    Calculation of predictive value (positive and negative) of cytology / the reference is histology of biopsy

  2. Feasibility of cytology

    Time frame: Baseline

    sample rate not satisfactory= hemorrhage hiding the cells of interest

  3. Feasibility of cytology

    Time frame: Baseline

    sample rate not satisfactory : low cellularity of the material

  4. Reproducibility intra and inter observers (coefficient of kappa de cohen)

    Time frame: Baseline

    reproducibility intra and inter observers of cytology interpretation (kappa de cohen)

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

Interest of Cytological Screening for Early Diagnosis of Precancerous or Cancerous Lesions of Oral Cavity by Transepithelial Brushing in Liquid-based

Acronym: Cytobuccale

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Nov 13, 2015
Registry last updated
Apr 17, 2019

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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