NCT02604121

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

February 1, 2013

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

August 18, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 13, 2015

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

April 17, 2019

Status Verified

April 1, 2019

Enrollment Period

6 years

First QC Date

August 18, 2015

Last Update Submit

April 16, 2019

Conditions

Mouth Neoplasms

Keywords

oral cavitycancerous and precancerous lesions

Outcome Measures

Primary Outcomes (1)

  • Diagnostic validity of lesion (Bethesda system, 2001)

    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

    baseline

Secondary Outcomes (4)

  • Diagnostic validity - predictive value (positive and negative)

    baseline

  • Feasibility of cytology

    Baseline

  • Feasibility of cytology

    Baseline

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

    Baseline

Study Arms (1)

transepithelial brushing

EXPERIMENTAL

transepithelial brushing in liquid-based technology + biopsy

Device: Orcellex® Rovers brush

Interventions

Orcellex® Rovers brushDEVICE

transepithelial brushing

transepithelial brushing

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • pregnant or lactating women
  • patients under juridical protection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Toulouse

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Mouth Neoplasms

Condition Hierarchy (Ancestors)

Head and Neck NeoplasmsNeoplasms by SiteNeoplasmsMouth DiseasesStomatognathic Diseases

Study Officials

  • Laetitia COLIN-LACOSTE, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 18, 2015

First Posted

November 13, 2015

Study Start

February 1, 2013

Primary Completion

February 1, 2019

Study Completion

February 1, 2019

Last Updated

April 17, 2019

Record last verified: 2019-04

Locations

FR(1)