Excision Limits of Oral Cavity Tumor by Narrow Band Imaging

Phase 2

Terminated

• Conditions: Cancer
• Interventions: Device: Location of the suspected lesions; Procedure: Biopsy; Procedure: Lesion excision/Surgery

• Registration Number: NCT01198119
• Lead Sponsor: Centre Oscar Lambret

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-09-08
• Study First Submitted QC: 2010-09-08
• Study First Posted: 2010-09-09
• Primary Completion: 2012-03
• Status Verified: 2012-07
• Study Completion: 2012-07
• Last Update Submitted: 2012-07-31
• Last Update Posted: 2012-08-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 23

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

Exclusion Criteria

• Metastatic or recurrent disease
• Health care impossibilities for geographic, social, psychic reasons

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patient with oral cavity cancer	Location of the suspected lesions	Patient treated by surgery for the oral cavity cancer
Patient with oral cavity cancer	Biopsy	Patient treated by surgery for the oral cavity cancer
Patient with oral cavity cancer	Lesion excision/Surgery	Patient treated by surgery for the oral cavity cancer

Primary Outcome Measures

Name	Time	Method
Reliability for detection of subclinical lesions	baseline	Concordance between the histological data and the lesions detected by the NBI technique

Secondary Outcome Measures

Name	Time	Method
Excision limits quality criteria	baseline	percentage of detection / percentage of false-negative
Detection of suspect lesions	baseline	Identify the detection of suspect lesions, aloof from the primitive lesion (percentage of detection / percentage of true-positive)

Trial Locations

Locations (1)

Centre Oscar Lambret; 🇫🇷 Lille, France