Concordance of Two Endoscopic Procedures for Diagnosis of Carcinoma of the Upper Aerodigestive Tract (TNFE-NBI)
|Upper Aerodigestive Tract Lesions Neoplasms, Oropharyngeal Oropharyngeal Cancer Neoplasms, Hypopharyngeal Hypopharyngeal Cancer Head and Neck Neoplasms UADT Neoplasms Carcinoma, Squamous Cell Papilloma||Device: Direct Rigid Endoscopy Device: Transnasal Flexible Endoscopy with Narrowband Imaging|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
|Official Title:||Accuracy of Endoscopic Diagnosis of Carcinoma of the UpperAerodigestive Tract: A Tandem Trial of Direct Rigid Endoscopy and Transnasal Flexible Endoscopy With Narrowband Imaging|
- Agreement between TNFE-NBI and DRE [ Time Frame: Within approximately 6 weeks of enrollment, after both diagnostic procedures have been completed ]
At the conclusion of study enrollment, all biopsy specimens will be coded, de-identified, and re-evaluated by the study pathologist in a blinded fashion. The code will be broken for the purposes of study analyses.
If all biopsies taken by both procedures on each patient are diagnosed as non-malignant upon blinded evaluation by the study pathologist or if both procedures have at least one biopsy diagnosed as malignant, this will be considered concordance.
- Agreement of TNFE-NBI and DRE on tumor stage and location [ Time Frame: Within approximately 6 weeks of enrollment, after both diagnostic procedures have been completed ]Describe differences, if any, in characterization of AJCC cTNM stage and tumor location as determined by TNFE-NBI as compared to standard-of-care DRE
- Agreement between TNFE-NBI and DRE on biopsy location selection [ Time Frame: Within approximately 6 weeks of enrollment, after both diagnostic procedures have been completed ]describe differences, if any, in biopsy location during TNFE-NBI as compared to standard-of-care DRE
- False negative diagnoses by TNFE-NBI or DRE [ Time Frame: Approximately 4 months after enrollment, after completion of both procedures and 3-month follow-up for non-malignant diagnoses ]To describe the frequency of detecting malignancy at a 3-month follow-up for patients initially diagnosed as negative for malignancy by both TNFE NBI and DRE evaluations
- Frequency and Timing of Adverse Events [ Time Frame: Within approximately 6 weeks of enrollment, after both diagnostic procedures have been completed and patient follow-up at 30 days ]The frequency by grade for all adverse events will be tabulated by type and procedure as well as timing (during or immediately following study procedure vs. follow-up).
- Describe patient tolerance for TNFE-NBI [ Time Frame: At the time of TNFE-NBI procedure, study day 1 ]Patients who have fulfilled the inclusion criteria and are unable to tolerate the unsedated examination will be classified as having non-concordance between TNFE-NBI and DRE (because a diagnosis could not be made based upon pathology) and the reason for intolerance to the procedure recorded.
|Study Start Date:||July 2010|
Device: Direct Rigid Endoscopy
Please refer to this study by its ClinicalTrials.gov identifier: NCT01175499
|Principal Investigator:||Mark S. Courey, MD||UCSF Helen Diller Family Comprehensive Cancer Center, Otolaryngology, Head & Neck Surgery|