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Clinical Trials/NCT01626638
NCT01626638
Completed
Not Applicable

Clinical Evaluation of Confocal Microscopy in Head and Neck Cancer

Gustave Roussy, Cancer Campus, Grand Paris2 sites in 1 country44 target enrollmentFebruary 1, 2013
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ConditionsMalignant Pharyngo Laryngeal TumorsPre-malignant Pharyngo Laryngeal Tumors

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Malignant Pharyngo Laryngeal Tumors
Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Enrollment
44
Locations
2
Primary Endpoint
Diagnostic correlation between confocal micro endoscopy and conventional histology
Status
Completed
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2013
End Date
May 24, 2017
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Diagnostic correlation between confocal micro endoscopy and conventional histology

Time Frame: at an average of 18 months

Secondary Outcomes

  • Histological diagnostic with confocal micro endoscopy (MEC) VS conventional histological analysis(At the time of the biopsy)

Study Sites (2)

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