Clinical Trial

CytID Analysis of Oral Lesions

Study Description

CytID Analysis of Oral Lesions

The purpose of this study is to correlate the results from a standard of care biopsy with CytIDa"c and hpvIDa"c 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.

Location

Locations Selected Location

Methods

No pharmaceutical medication involved No pharmaceutical medication involved
Patients and healthy individuals accepted Patients and healthy individuals accepted

Oral examination with incandescent light

Suspicious oral lesions will be identified by oral examination with incandescent light.

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

CytIDâ„¢ 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

hpvIDâ„¢ 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 hpvIDâ„¢ trends with routine standard of care biopsy or cytology results.

Additional Information

Official Study Title

CytID Analysis of Oral Lesions

Clinical Trial ID

NCT03555721

ParticipAid ID

meprVb