CytID Analysis of Oral Lesions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Number of participants for whom biopsy and CytID results both indicate presence of malignant or premalignant oral lesions
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- 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
Outcomes
Primary Outcomes
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 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)
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)
Secondary Outcomes
No secondary outcomes reported
Investigators
Mark Nichols
Clinical Associate Professor
The University of Texas Health Science Center, Houston