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

This study is currently recruiting participants.
Verified January 2017 by Gustave Roussy, Cancer Campus, Grand Paris
Sponsor:
ClinicalTrials.gov Identifier:
NCT01626638
First Posted: June 25, 2012
Last Update Posted: January 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Gustave Roussy, Cancer Campus, Grand Paris
  Purpose
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.

Condition Intervention
Malignant Pharyngo Laryngeal Tumors Pre-malignant Pharyngo Laryngeal Tumors Procedure: Confocal Micro Endoscopy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Clinical Evaluation of Confocal Microscopy in Head and Neck Cancer

Resource links provided by NLM:


Further study details as provided by Gustave Roussy, Cancer Campus, Grand Paris:

Primary Outcome Measures:
  • Diagnostic correlation between confocal micro endoscopy and conventional histology [ Time Frame: at an average of 18 months ]

Secondary Outcome Measures:
  • Histological diagnostic with confocal micro endoscopy (MEC) VS conventional histological analysis [ Time Frame: At the time of the biopsy ]

Estimated Enrollment: 40
Study Start Date: February 2013
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental Procedure: Confocal Micro Endoscopy

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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): NCT01626638


Locations
France
Institut Gustave Roussy Recruiting
Villejuif, Val de Marne, France, 94805
Contact: Stéphane TEMAM, MD    +33 1 42 11 44 46      
Principal Investigator: Stéphane TEMAM, MD         
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
Ministry of Health, France
Investigators
Principal Investigator: Stéphane TEMAM, MD Gustave Roussy, Cancer Campus, Grand Paris
  More Information

Responsible Party: Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier: NCT01626638     History of Changes
Other Study ID Numbers: 2011-A00818-33
First Submitted: June 15, 2012
First Posted: June 25, 2012
Last Update Posted: January 26, 2017
Last Verified: January 2017

Keywords provided by Gustave Roussy, Cancer Campus, Grand Paris:
Patients with malignant and pre-malignant pharyngo laryngeal tumors

Additional relevant MeSH terms:
Neoplasms
Head and Neck Neoplasms
Precancerous Conditions
Laryngeal Neoplasms
Neoplasms by Site
Otorhinolaryngologic Neoplasms
Laryngeal Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Otorhinolaryngologic Diseases