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

NCT ID: NCT01626638

Last Updated: 2021-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-01

Study Completion Date

2017-05-24

Brief Summary

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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.

Detailed Description

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Conditions

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Malignant Pharyngo Laryngeal Tumors Pre-malignant Pharyngo Laryngeal Tumors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Experimental

Group Type EXPERIMENTAL

Confocal Micro Endoscopy

Intervention Type PROCEDURE

Interventions

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Confocal Micro Endoscopy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, France

OTHER_GOV

Sponsor Role collaborator

Gustave Roussy, Cancer Campus, Grand Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stéphane TEMAM, MD

Role: PRINCIPAL_INVESTIGATOR

Gustave Roussy, Cancer Campus, Grand Paris

Locations

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Institut Gustave Roussy

Villejuif, Val De Marne, France

Site Status

Institut Universitaire Du Cancer de Toulouse - Oncopole

Toulouse, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 35316771 (View on PubMed)

Other Identifiers

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2011-A00818-33

Identifier Type: -

Identifier Source: org_study_id

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