CytID Analysis of Oral Lesions

The University of Texas System (UT)

Status: Terminated

Conditions: Oropharyngeal Cancer; Oral Cavity Cancer

Treatments: Other: Oral examination with OralID; Diagnostic Test: hpvID; Diagnostic Test: CytID; Diagnostic Test: Biopsy; Other: Oral examination with incandescent light

Study type: Observational

Funder types: Other

Identifiers

NCT03555721

HSC-GEN-17-1067

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Receive care at the Avenue 360 Health and Wellness Clinic, a not for profit dental clinic in the Montrose area of Houston
• Present with a potentially malignant oral lesion (PMOL) for whom a biopsy is deemed necessary

Exclusion criteria

• Do not receive care at the Avenue 360 Health and Wellness Clinic, a not for profit dental clinic in the Montrose area of Houston
• Do not present with a potentially malignant oral lesion (PMOL) for whom a biopsy is deemed necessary

Trial design

18 participants in 1 patient group

Oral examination followed by biopsy, CytID, and hpvID

Description:

Identification of oral lesions with oral examination with both incandescent light and fluorescent light (OralID), and subsequent testing of suspicious oral lesions with biopsy, CytID, and hpvID

Treatment:

Diagnostic Test: Biopsy

Other: Oral examination with incandescent light

Diagnostic Test: hpvID

Diagnostic Test: CytID

Other: Oral examination with OralID