Concordance of Two Endoscopic Procedures for Diagnosis of Carcinoma of the Upper Aerodigestive Tract (TNFE-NBI)
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 TNFE-NBI with biopsy of suspicious lesions prior to planned regular clinical care (DRE). Biopsies will be evaluated by standard clinical methods for patient diagnoses and care. As the current standard of care, if all biopsies for a given patient are non-malignant, a 3 month office visit will be arranged to evaluate and determine the need for further intervention. At the end of study enrollment both sets of biopsies will be re-evaluated in a blinded fashion by the surgical pathologist. Study assessment of malignant vs. non-malignant (benign) pathology will be used to see whether both tests tended to agree on diagnoses.
Upper Aerodigestive Tract Lesions
Head and Neck Neoplasms
Carcinoma, Squamous Cell
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]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|
|Estimated Study Completion Date:||October 2015|
|Estimated Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
Device: Direct Rigid Endoscopy
Please refer to this study by its ClinicalTrials.gov identifier: NCT01175499
|United States, California|
|University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center||Recruiting|
|San Francisco, California, United States, 94115|
|Contact: Clinical Trials Office - UCSF Helen Diller Family Comprehensive Cancer Center 877-827-3222 firstname.lastname@example.org|
|Principal Investigator: Mark S. Courey, MD|
|Sub-Investigator: Matthew S. Russell, MD|
|Sub-Investigator: Katherine Yung, MD|
|Sub-Investigator: Theodore Miller, MD|
|Principal Investigator:||Mark S. Courey, MD||UCSF Helen Diller Family Comprehensive Cancer Center, Otolaryngology, Head & Neck Surgery|