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Excision Limits of Oral Cavity Tumor by Narrow Band Imaging

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ClinicalTrials.gov Identifier: NCT01198119
Recruitment Status : Terminated (lack of recruitment)
First Posted : September 9, 2010
Last Update Posted : August 1, 2012
Sponsor:
Information provided by (Responsible Party):
Centre Oscar Lambret

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

Condition or disease Intervention/treatment Phase
Cancer Device: Location of the suspected lesions Procedure: Biopsy Procedure: Lesion excision/Surgery Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Excision Limits of Oral Cavity Tumor by NARROW BAND IMAGING (NBI): Feasibility Trial
Study Start Date : July 2010
Actual Primary Completion Date : March 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oral Cancer

Arm Intervention/treatment
Experimental: Patient with oral cavity cancer
Patient treated by surgery for the oral cavity cancer
Device: 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

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

Procedure: Lesion excision/Surgery
In case of positive biopsy, the suspected lesions is excised




Primary Outcome Measures :
  1. Reliability for detection of subclinical lesions [ Time Frame: baseline ]
    Concordance between the histological data and the lesions detected by the NBI technique


Secondary Outcome Measures :
  1. Excision limits quality criteria [ Time Frame: baseline ]
    percentage of detection / percentage of false-negative

  2. Detection of suspect lesions [ Time Frame: baseline ]
    Identify the detection of suspect lesions, aloof from the primitive lesion (percentage of detection / percentage of true-positive)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01198119


Locations
France
Centre Oscar Lambret
Lille, France, 59020
Sponsors and Collaborators
Centre Oscar Lambret
Investigators
Principal Investigator: Sophie EL BEDOUI, MD Centre Oscar Lambret

Responsible Party: Centre Oscar Lambret
ClinicalTrials.gov Identifier: NCT01198119     History of Changes
Other Study ID Numbers: NBI-CAB-0907
First Posted: September 9, 2010    Key Record Dates
Last Update Posted: August 1, 2012
Last Verified: July 2012

Keywords provided by Centre Oscar Lambret:
oral cavity tumor
narrow band imaging
subclinical cancer lesion

Additional relevant MeSH terms:
Mouth Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Mouth Diseases
Stomatognathic Diseases