Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
Study Type
Observational
Observational Model
Other
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Oral examination followed by biopsy, CytID, and hpvID 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
  • 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.

Recruiting Locations

The University of Texas Health Science Center at Houston
Houston, Texas 77030
Contact:
Clifton M Nichols, DDS
713-341-3793
mnichols@avenue360.org

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

Clifton M Nichols, DDS
713-341-3793
mnichols@avenue360.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.