CytID Analysis of Oral Lesions

Study Overview
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Brief Summary
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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.

Official Title
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CytID Analysis of Oral Lesions

Conditions
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Oral Cavity Cancer, Oropharyngeal Cancer

Intervention / Treatment
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* Other: Oral examination with incandescent light
* Other: Oral examination with OralID
* Diagnostic Test: Biopsy
* Diagnostic Test: CytID
* Diagnostic Test: hpvID


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Oral examination followed by biopsy, CytID, and hpvID<br>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<br>* Suspicious oral lesions will be identified by oral examination with incandescent light.<br>Other: Oral examination with OralID<br>* 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.<br>Diagnostic Test: Biopsy<br>* Tissue will be collected to identify pre-cancerous or cancerous cells<br>Diagnostic Test: CytID<br>* 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.<br>Diagnostic Test: hpvID<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants for whom biopsy and CytID results both indicate presence of malignant or premalignant oral lesions |  | 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 |  | 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 |  | 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 |  | 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 |  | 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 |  | day 1 (at the time of oral examination) |