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

NCT ID: NCT02604121

Last Updated: 2019-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2019-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Mouth Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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transepithelial brushing

transepithelial brushing in liquid-based technology + biopsy

Group Type EXPERIMENTAL

Orcellex® Rovers brush

Intervention Type DEVICE

transepithelial brushing

Interventions

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Orcellex® Rovers brush

transepithelial brushing

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laetitia COLIN-LACOSTE, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

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University Hospital Toulouse

Toulouse, , France

Site Status

Countries

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France

Other Identifiers

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12 045 03

Identifier Type: -

Identifier Source: org_study_id

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