Excision Limits of Oral Cavity Tumor by Narrow Band Imaging

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

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2012-07-31

Brief Summary

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This study evaluates the feasibility of the NBI technique in the detection of early cancer lesions.

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Detailed Description

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Conditions

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Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patient with oral cavity cancer

Patient treated by surgery for the oral cavity cancer

Group Type EXPERIMENTAL

Location of the suspected lesions

Intervention Type DEVICE

The suspected lesions will be located before the excision, during the surgery.

1. With traditional light
2. NBI technique The images will be recorded and compared

Biopsy

Intervention Type PROCEDURE

In case of suspected lesions detected by the NBI technique, this area is biopsied

Lesion excision/Surgery

Intervention Type PROCEDURE

In case of positive biopsy, the suspected lesions is excised

Interventions

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Location of the suspected lesions

The suspected lesions will be located before the excision, during the surgery.

1. With traditional light
2. NBI technique The images will be recorded and compared

Intervention Type DEVICE

Biopsy

In case of suspected lesions detected by the NBI technique, this area is biopsied

Intervention Type PROCEDURE

Lesion excision/Surgery

In case of positive biopsy, the suspected lesions is excised

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Primitive epidermoid cancer of the oral cavity, proved by histology, not treated previously, patient having a surgery
* No previous surgery for this cancer
* Age \> 18 years
* Patient affiliated to health insurance
* Consent signed by the patient