Head and Neck Neoplasms Clinical Trial
— TNFE-NBIOfficial 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
NCT number | NCT01175499 |
Other study ID # | 10-00166 |
Secondary ID | 10201 |
Status | Withdrawn |
Phase | N/A |
First received | July 20, 2010 |
Last updated | August 15, 2014 |
Start date | July 2010 |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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. |
Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Agreement between TNFE-NBI and DRE | 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. |
Within approximately 6 weeks of enrollment, after both diagnostic procedures have been completed | No |
Secondary | Agreement of TNFE-NBI and DRE on tumor stage and location | 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 | Within approximately 6 weeks of enrollment, after both diagnostic procedures have been completed | No |
Secondary | Agreement between TNFE-NBI and DRE on biopsy location selection | describe differences, if any, in biopsy location during TNFE-NBI as compared to standard-of-care DRE | Within approximately 6 weeks of enrollment, after both diagnostic procedures have been completed | No |
Secondary | False negative diagnoses by TNFE-NBI or DRE | 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 | Approximately 4 months after enrollment, after completion of both procedures and 3-month follow-up for non-malignant diagnoses | Yes |
Secondary | Frequency and Timing of Adverse Events | 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). | Within approximately 6 weeks of enrollment, after both diagnostic procedures have been completed and patient follow-up at 30 days | Yes |
Secondary | Describe patient tolerance for TNFE-NBI | 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. | At the time of TNFE-NBI procedure, study day 1 | Yes |
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