NCT03555721

CytID Analysis of Oral Lesions

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 18 (actual)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to correlate the results from a standard of care biopsy with CytID™ and hpvID™ swab tests for potentially premalignant and malignant oral lesions. The biopsy is considered standard of care and will be performed regardless of the patient's enrollment in the study. The study-related data gathering will not influence the treatment decisions of the clinician.

Conditions

• Oral Cavity Cancer
• Oropharyngeal Cancer

Interventions

Type	Name	Description
OTHER	Oral examination with incandescent light	Suspicious oral lesions will be identified by oral examination with incandescent light.
OTHER	Oral examination with OralID	OralID uses a proven, optically based fluorescence technology that provides the clinician an aid in visualization of oral cancer, pre-cancer and other abnormal lesions.
DIAGNOSTIC_TEST	Biopsy	Tissue will be collected to identify pre-cancerous or cancerous cells
DIAGNOSTIC_TEST	CytID	CytID™ is an adjunctive process that is a noninvasive, pain-free, chair-side procedure for assessment of suspicious oral cavity lesions using a brush swab. The test is based on an objective measure of gross changes in the nuclear DNA content of oral epithelial cells; thereby, providing information about the pre-cancerous or cancerous state of a lesion.
DIAGNOSTIC_TEST	hpvID	hpvID™ testing can detect all major HPV types and shows the current HPV status of the patient. This provides additional clinical information to correlate and compare hpvID™ trends with routine standard of care biopsy or cytology results.

Timeline

• Start date: 2018-05-30
• Primary completion: 2022-11-01
• Completion: 2022-11-01
• First posted: 2018-06-13
• Last updated: 2023-05-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study