CytID Analysis of Oral Lesions
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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.
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Outcome Measures
Primary Outcome Measures
- 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)]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Receive care at the Avenue 360 Health and Wellness Clinic, a not for profit dental clinic in the Montrose area of Houston
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Present with a potentially malignant oral lesion (PMOL) for whom a biopsy is deemed necessary
Exclusion Criteria:
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Do not receive care at the Avenue 360 Health and Wellness Clinic, a not for profit dental clinic in the Montrose area of Houston
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Do not present with a potentially malignant oral lesion (PMOL) for whom a biopsy is deemed necessary
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The University of Texas Health Science Center at Houston | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- The University of Texas Health Science Center, Houston
- M.D. Anderson Cancer Center
Investigators
- Principal Investigator: Clifton M Nichols, DDS, The University of Texas Health Science Center, Houston
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HSC-GEN-17-1067