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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

September 8, 2010
September 9, 2010
August 1, 2012
July 2010
March 2012   (Final data collection date for primary outcome measure)
Reliability for detection of subclinical lesions [ Time Frame: baseline ]
Concordance between the histological data and the lesions detected by the NBI technique
Reliability for detection of subclinical lesions [ Time Frame: During surgery ]
Concordance between the histological data and the lesions detected by the NBI technique
Complete list of historical versions of study NCT01198119 on ClinicalTrials.gov Archive Site
  • Excision limits quality criteria [ Time Frame: baseline ]
    percentage of detection / percentage of false-negative
  • 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)
  • Excision limits quality criteria [ Time Frame: During surgery ]
    percentage of detection / percentage of false-negative
  • Detection of suspect lesions [ Time Frame: during study ]
    Identify the detection of suspect lesions, aloof from the primitive lesion (percentage of detection / percentage of true-positive)
Not Provided
Not Provided
 
Excision Limits of Oral Cavity Tumor by Narrow Band Imaging
Excision Limits of Oral Cavity Tumor by NARROW BAND IMAGING (NBI): Feasibility Trial
This study evaluates the feasibility of the NBI technique in the detection of early cancer lesions.
Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Experimental: Patient with oral cavity cancer
Patient treated by surgery for the oral cavity cancer
Interventions:
  • Device: Location of the suspected lesions
  • Procedure: Biopsy
  • Procedure: Lesion excision/Surgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
23
86
July 2012
March 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01198119
NBI-CAB-0907
No
Not Provided
Not Provided
Centre Oscar Lambret
Centre Oscar Lambret
Not Provided
Principal Investigator: Sophie EL BEDOUI, MD Centre Oscar Lambret
Centre Oscar Lambret
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP