ID

36129

Description

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. ODM derived from: https://clinicaltrials.gov/show/NCT01175499

Link

https://clinicaltrials.gov/show/NCT01175499

Keywords

Versions (1)
  1. 4/17/19 4/17/19 -
Copyright Holder

University of California, San Francisco

Uploaded on

April 17, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Concordance of Two Endoscopic Procedures for Diagnosis of Carcinoma of the Upper Aerodigestive Tract NCT01175499

English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
Patient aged 18 years or older
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Patient is pending operative direct laryngoscopy as standard clinical care
Description

Direct laryngoscopy

Data type

boolean

Alias
UMLS CUI [1,1]
C0189281
UMLS CUI [1,2]
C1611271
Patient with presence of upper aerodigestive tract 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
Description

Upper aerodigestive tract = oropharyngeal, hypopharyngeal and/or glottic mucosal

Data type

boolean

Alias
UMLS CUI [1,1]
C1267213
UMLS CUI [1,2]
C0221198
UMLS CUI [1,3]
C4050405
UMLS CUI [2]
C0007137
UMLS CUI [3]
C0007099
UMLS CUI [4,1]
C0334044
UMLS CUI [4,2]
C1182670
UMLS CUI [5]
C0030354
UMLS CUI [6,1]
C0334246
UMLS CUI [6,2]
C0027530
UMLS CUI [6,3]
C0449695
UMLS CUI [6,4]
C0439673
Patient is able to give written informed consent and is willing to comply with the requirements of the protocol
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0085732
UMLS CUI [2,1]
C4319828
UMLS CUI [2,2]
C0600109
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
Patient is medically not able to undergo TNFE
Description

TNFE = Transnasal Flexible Endoscopy

Data type

boolean

Alias
UMLS CUI [1,1]
C3897344
UMLS CUI [1,2]
C0443220
UMLS CUI [1,3]
C0014245
UMLS CUI [1,4]
C1299582
Patient has an allergy to topical anesthesia
Description

Topical anesthesia

Data type

boolean

Alias
UMLS CUI [1,1]
C0472473
UMLS CUI [1,2]
C0020517
Patient has an active lymphoma
Description

Lymphoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0024299
UMLS CUI [1,2]
C0205177
Patient's lesion is inaccessible to TNFE: oral cavity (anterior 2/3 tongue, buccal mucosa)
Description

TNFE = Transnasal Flexible Endoscopy

Data type

boolean

Alias
UMLS CUI [1,1]
C2184261
UMLS CUI [1,2]
C0226896
UMLS CUI [2,1]
C2184261
UMLS CUI [2,2]
C4048706
UMLS CUI [2,3]
C3897344
UMLS CUI [2,4]
C0443220
UMLS CUI [2,5]
C0014245
Patient with coagulopathy: INR ≥ 1.5
Description

Coagulopathy

Data type

boolean

Alias
UMLS CUI [1]
C0005779
UMLS CUI [2]
C0853225
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.
Description

Compliance compromise

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C2945640
UMLS CUI [1,3]
C1321605
UMLS CUI [2]
C0003467
UMLS CUI [3,1]
C1283892
UMLS CUI [3,2]
C0333164
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
Patient aged 18 years or older
boolean
C0001779 (UMLS CUI [1])
Direct laryngoscopy
Item
Patient is pending operative direct laryngoscopy as standard clinical care
boolean
C0189281 (UMLS CUI [1,1])
C1611271 (UMLS CUI [1,2])
Suspicious lesion
Item
Patient with presence of upper aerodigestive tract 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
boolean
C1267213 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C4050405 (UMLS CUI [1,3])
C0007137 (UMLS CUI [2])
C0007099 (UMLS CUI [3])
C0334044 (UMLS CUI [4,1])
C1182670 (UMLS CUI [4,2])
C0030354 (UMLS CUI [5])
C0334246 (UMLS CUI [6,1])
C0027530 (UMLS CUI [6,2])
C0449695 (UMLS CUI [6,3])
C0439673 (UMLS CUI [6,4])
Informed consent
Item
Patient is able to give written informed consent and is willing to comply with the requirements of the protocol
boolean
C0021430 (UMLS CUI [1,1])
C0085732 (UMLS CUI [1,2])
C4319828 (UMLS CUI [2,1])
C0600109 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
TNFE
Item
Patient is medically not able to undergo TNFE
boolean
C3897344 (UMLS CUI [1,1])
C0443220 (UMLS CUI [1,2])
C0014245 (UMLS CUI [1,3])
C1299582 (UMLS CUI [1,4])
Topical anesthesia
Item
Patient has an allergy to topical anesthesia
boolean
C0472473 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
Lymphoma
Item
Patient has an active lymphoma
boolean
C0024299 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
Lesion inaccessibility
Item
Patient's lesion is inaccessible to TNFE: oral cavity (anterior 2/3 tongue, buccal mucosa)
boolean
C2184261 (UMLS CUI [1,1])
C0226896 (UMLS CUI [1,2])
C2184261 (UMLS CUI [2,1])
C4048706 (UMLS CUI [2,2])
C3897344 (UMLS CUI [2,3])
C0443220 (UMLS CUI [2,4])
C0014245 (UMLS CUI [2,5])
Coagulopathy
Item
Patient with coagulopathy: INR ≥ 1.5
boolean
C0005779 (UMLS CUI [1])
C0853225 (UMLS CUI [2])
Compliance compromise
Item
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.
boolean
C0348080 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C1321605 (UMLS CUI [1,3])
C0003467 (UMLS CUI [2])
C1283892 (UMLS CUI [3,1])
C0333164 (UMLS CUI [3,2])
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