Concordance of Two Endoscopic Procedures for Diagnosis of Carcinoma of the Upper Aerodigestive Tract (TNFE-NBI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by University of California, San Francisco
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01175499
First received: July 20, 2010
Last updated: September 23, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
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 Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 88
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)
Intervention Details:
    Device: Direct Rigid Endoscopy
    Laryngoscopy is performed under general anesthesia with a rigid laryngoscope. Mucosal surfaces of the oropharynx, hypopharynx, and glottis (base of tongue, vallecula, epiglottis, aryepiglottic folds, arytenoids, piriform sinuses, true and false vocal cords, and esophageal inlet) are systematically visualized. Areas of irregularity are biopsied with 2mm and/or 4mm cupped forceps. Esophagoscopy and bronchoscopy will be performed per the standard of care.
    Other Name: Rigid laryngoscope
    Device: Transnasal Flexible Endoscopy with Narrowband Imaging
    Transnasal flexible endoscopy with and without narrowband imaging- additional diagnostic test. This examination is performed after topical intranasal anesthesia with 2% Pontocaine spray. A fiberoptic laryngoscope is passed into the nasal cavity to the pharynx where mucosal surfaces of the UADT can be visualized. The optics of a standard fiberoptic scope are generally considered to be inferior to direct visualization. The addition of narrowband imaging does not change the procedure, but enhances visualization of the mucosal vasculature. Biopsies are performed through a second channel in the endoscope with 1.8mm cupped forceps and will require an additional dose of topical anesthesia.
    Other Name: EVIS EXERA 160A System
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01175499

Locations
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    crss@cc.ucsf.edu   
Principal Investigator: Mark S. Courey, MD         
Sub-Investigator: Matthew S. Russell, MD         
Sub-Investigator: Katherine Yung, MD         
Sub-Investigator: Theodore Miller, MD         
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Mark S. Courey, MD UCSF Helen Diller Family Comprehensive Cancer Center, Otolaryngology, Head & Neck Surgery
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01175499     History of Changes
Other Study ID Numbers: 10-00166, 10201
Study First Received: July 20, 2010
Last Updated: September 23, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, San Francisco:
laryngoscopy
Laryngoscopic Surgery
laryngoscopes
upper aerodigestive tract lesions
endoscopy
biopsy

Additional relevant MeSH terms:
Neoplasms
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Hypopharyngeal Neoplasms
Oropharyngeal Neoplasms
Papilloma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Neoplasms by Site
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on July 22, 2014