Clinical trial · Interventional

Concordance of Two Endoscopic Procedures for Diagnosis of Carcinoma of the Upper Aerodigestive Tract

Accuracy of Endoscopic Diagnosis of Carcinoma of the UpperAerodigestive Tract: A Tandem Trial of Direct Rigid Endoscopy and Transnasal Flexible Endoscopy With Narrowband Imaging

NCT01175499CI-TRIAL-00015419TNFE-NBIwithdrawnN/AClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Why stopped (as posted): Unable to obtain funding to continue recruitment; no accrual

Summary

Brief summary (as posted)

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.

Conditions

Conditions (9)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Carcinoma, Squamous Cell	Squamous Cell Carcinoma	ONTOLOGY_EXACT	0.98
Head and Neck Neoplasms	Head and Neck Neoplasm	ONTOLOGY_EXACT	0.98
Hypopharyngeal Cancer	Malignant Hypopharyngeal Neoplasm	CURATED_EXACT	0.92
Neoplasms, Hypopharyngeal	Hypopharyngeal Neoplasm	ONTOLOGY_EXACT	0.98
Neoplasms, Oropharyngeal	Oropharyngeal Neoplasm	ONTOLOGY_EXACT	0.98
Oropharyngeal Cancer	Malignant Oropharyngeal Neoplasm	CURATED_EXACT	0.92
Papilloma	Papilloma	ONTOLOGY_EXACT	0.98
UADT Neoplasms

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
Direct Rigid Endoscopy	Device	—	UNRESOLVED
Transnasal Flexible Endoscopy with Narrowband Imaging	Device	—	UNRESOLVED

Design

Arms and outcomes

Arms (0)

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Primary outcomes (1)

measure
Agreement between TNFE-NBI and DRE
timeFrame
Within approximately 6 weeks of enrollment, after both diagnostic procedures have been completed
description
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 outcomes (5)

measure
Agreement of TNFE-NBI and DRE on tumor stage and location
timeFrame
Within approximately 6 weeks of enrollment, after both diagnostic procedures have been completed
description
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
measure
Agreement between TNFE-NBI and DRE on biopsy location selection

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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.

References

Publications (0)

Data not yet available

No reference posted for this study.