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Confocal Micro-endoscopy in Head and Neck Cancer/Micro Endoscopie Confocale (MEC)Oto-Rhino-Laryngologie (ORL) (MEC ORL)

Primary Purpose

Malignant Pharyngo Laryngeal Tumors, Pre-malignant Pharyngo Laryngeal Tumors

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Confocal Micro Endoscopy
Sponsored by
Gustave Roussy, Cancer Campus, Grand Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Malignant Pharyngo Laryngeal Tumors focused on measuring Patients with malignant and pre-malignant pharyngo laryngeal tumors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with malignant and pre-malignant pharyngo laryngeal tumors in whom direct laryngoscopy was performed under general anesthesia with biopsies for diagnostic or endoscopic removal
  • > 18 years
  • signed ICF

Exclusion Criteria:

  • Persons deprived of liberty
  • Patients with history of allergy to patent blue
  • Pregnant women or breastfeeding women

Sites / Locations

  • Institut Gustave Roussy
  • Institut Universitaire Du Cancer de Toulouse - Oncopole

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental

Arm Description

Outcomes

Primary Outcome Measures

Diagnostic correlation between confocal micro endoscopy and conventional histology

Secondary Outcome Measures

Histological diagnostic with confocal micro endoscopy (MEC) VS conventional histological analysis

Full Information

First Posted
June 15, 2012
Last Updated
February 17, 2021
Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Collaborators
Ministry of Health, France
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1. Study Identification

Unique Protocol Identification Number
NCT01626638
Brief Title
Confocal Micro-endoscopy in Head and Neck Cancer/Micro Endoscopie Confocale (MEC)Oto-Rhino-Laryngologie (ORL)
Acronym
MEC ORL
Official Title
Clinical Evaluation of Confocal Microscopy in Head and Neck Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2013 (Actual)
Primary Completion Date
May 24, 2017 (Actual)
Study Completion Date
May 24, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Collaborators
Ministry of Health, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective is to validate the diagnostic correlation between the intraoperative microendoscopic images and the conventional histological analysis on biopsy and/or surgical specimens on patients with epidermoid carcinoma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Pharyngo Laryngeal Tumors, Pre-malignant Pharyngo Laryngeal Tumors
Keywords
Patients with malignant and pre-malignant pharyngo laryngeal tumors

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Confocal Micro Endoscopy
Primary Outcome Measure Information:
Title
Diagnostic correlation between confocal micro endoscopy and conventional histology
Time Frame
at an average of 18 months
Secondary Outcome Measure Information:
Title
Histological diagnostic with confocal micro endoscopy (MEC) VS conventional histological analysis
Time Frame
At the time of the biopsy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with malignant and pre-malignant pharyngo laryngeal tumors in whom direct laryngoscopy was performed under general anesthesia with biopsies for diagnostic or endoscopic removal > 18 years signed ICF Exclusion Criteria: Persons deprived of liberty Patients with history of allergy to patent blue Pregnant women or breastfeeding women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stéphane TEMAM, MD
Organizational Affiliation
Gustave Roussy, Cancer Campus, Grand Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Gustave Roussy
City
Villejuif
State/Province
Val De Marne
ZIP/Postal Code
94805
Country
France
Facility Name
Institut Universitaire Du Cancer de Toulouse - Oncopole
City
Toulouse
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
35316771
Citation
Villard A, Breuskin I, Casiraghi O, Asmandar S, Laplace-Builhe C, Abbaci M, Moya Plana A. Confocal laser endomicroscopy and confocal microscopy for head and neck cancer imaging: Recent updates and future perspectives. Oral Oncol. 2022 Apr;127:105826. doi: 10.1016/j.oraloncology.2022.105826. Epub 2022 Mar 19.
Results Reference
derived

Learn more about this trial

Confocal Micro-endoscopy in Head and Neck Cancer/Micro Endoscopie Confocale (MEC)Oto-Rhino-Laryngologie (ORL)

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