CytID Analysis of Oral Lesions

Overview

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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: November 1, 2022

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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

Clinical Trial Outcome Measures

Primary Measures

  • Number of participants for whom biopsy and CytID results both indicate presence of malignant or premalignant oral lesions
    • Time Frame: day 1 (at the time of oral examination)
  • Number of participants for whom biopsy indicates presence of malignant or premalignant oral lesions and hpvID indicates presence of HPV
    • Time Frame: day 1 (at the time of oral examination)
  • Number of participants for whom biopsy results, but not CytID results, indicate presence of malignant or premalignant oral lesions
    • Time Frame: day 1 (at the time of oral examination)
  • Number of participants for whom CytID results, but not biopsy results, indicate presence of malignant or premalignant oral lesions
    • Time Frame: day 1 (at the time of oral examination)
  • Number of participants for whom biopsy does not indicate presence of malignant or premalignant oral lesions, but hpvID indicates presence of HPV
    • Time Frame: day 1 (at the time of oral examination)
  • Number of participants for whom biopsy indicates presence of malignant or premalignant oral lesions, but hpvID does not indicate presence of HPV
    • Time Frame: day 1 (at the time of oral examination)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • The University of Texas Health Science Center, Houston
  • Collaborator
    • M.D. Anderson Cancer Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Mark Nichols, Clinical Associate Professor – The University of Texas Health Science Center, Houston
  • Overall Official(s)
    • Clifton M Nichols, DDS, Principal Investigator, The University of Texas Health Science Center, Houston

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