Back to resultsExcision Limits of Oral Cavity Tumor by Narrow Band Imaging
Primary Purpose
Cancer
Status
Terminated
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Location of the suspected lesions
Biopsy
Lesion excision/Surgery
Sponsored by
About this trial
This is an interventional diagnostic trial for Cancer focused on measuring oral cavity tumor, narrow band imaging, subclinical cancer lesion
Eligibility 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
Sites / Locations
- Centre Oscar Lambret
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patient with oral cavity cancer
Arm Description
Patient treated by surgery for the oral cavity cancer
Outcomes
Primary Outcome Measures
Reliability for detection of subclinical lesions
Concordance between the histological data and the lesions detected by the NBI technique
Secondary Outcome Measures
Excision limits quality criteria
percentage of detection / percentage of false-negative
Detection of suspect lesions
Identify the detection of suspect lesions, aloof from the primitive lesion (percentage of detection / percentage of true-positive)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01198119
Brief Title
Excision Limits of Oral Cavity Tumor by Narrow Band Imaging
Official Title
Excision Limits of Oral Cavity Tumor by NARROW BAND IMAGING (NBI): Feasibility Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Terminated
Why Stopped
lack of recruitment
Study Start Date
July 2010 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Oscar Lambret
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study evaluates the feasibility of the NBI technique in the detection of early cancer lesions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer
Keywords
oral cavity tumor, narrow band imaging, subclinical cancer lesion
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patient with oral cavity cancer
Arm Type
Experimental
Arm Description
Patient treated by surgery for the oral cavity cancer
Intervention Type
Device
Intervention Name(s)
Location of the suspected lesions
Intervention Description
The suspected lesions will be located before the excision, during the surgery.
With traditional light
NBI technique The images will be recorded and compared
Intervention Type
Procedure
Intervention Name(s)
Biopsy
Intervention Description
In case of suspected lesions detected by the NBI technique, this area is biopsied
Intervention Type
Procedure
Intervention Name(s)
Lesion excision/Surgery
Intervention Description
In case of positive biopsy, the suspected lesions is excised
Primary Outcome Measure Information:
Title
Reliability for detection of subclinical lesions
Description
Concordance between the histological data and the lesions detected by the NBI technique
Time Frame
baseline
Secondary Outcome Measure Information:
Title
Excision limits quality criteria
Description
percentage of detection / percentage of false-negative
Time Frame
baseline
Title
Detection of suspect lesions
Description
Identify the detection of suspect lesions, aloof from the primitive lesion (percentage of detection / percentage of true-positive)
Time Frame
baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sophie EL BEDOUI, MD
Organizational Affiliation
Centre Oscar Lambret
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59020
Country
France
12. IPD Sharing Statement
Learn more about this trial
Excision Limits of Oral Cavity Tumor by Narrow Band Imaging
We'll reach out to this number within 24 hrs