Status:
WITHDRAWN
Concordance of Two Endoscopic Procedures for Diagnosis of Carcinoma of the Upper Aerodigestive Tract
Lead Sponsor:
University of California, San Francisco
Conditions:
Upper Aerodigestive Tract Lesions
Neoplasms, Oropharyngeal
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study will compare TNFE-NBI and biopsy, with DRE and biopsy for the diagnostic evaluation and staging of patients with suspicious UADT lesions. All patients enrolled in the study will undergo TNF...
Detailed Description
This is a single arm prospective study to evaluate the concordance between a standard-of-care diagnostic procedure and TNFE-NBI for diagnosing malignancy. The primary aim of this investigation is to d...
Eligibility Criteria
Inclusion
- Age eighteen years or older
- Patients who are pending operative direct laryngoscopy as standard clinical care
- Presence of upper aerodigestive tract (UADT) (oropharyngeal, hypopharyngeal and/or glottic mucosal) lesion(s) suspicious for diagnoses including but not limited to: squamous cell carcinoma, carcinoma in situ, squamous dysplasia, papilloma, OR presence of diagnosed metastatic squamous cell carcinoma in the neck with an unidentified primary lesion
- Ability to give written informed consent and willingness to comply with the requirements of the protocol
Exclusion
- Patients who are not medically able to undergo TNFE
- Allergy to topical anesthesia
- Active lymphoma
- Lesion inaccessibility to TNFE: oral cavity (anterior 2/3 tongue, buccal mucosa)
- Coagulopathy: INR ≥ 1.5
- Any condition that compromises compliance with the objectives and procedures of this protocol, as judged by the principal investigator such as anxiety or narrow nasal passage way.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01175499
Start Date
July 1 2010
Last Update
August 19 2014
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