Clinical trial NCT03555721: CytID Analysis of Oral Lesions
Official title: CytID Analysis of Oral Lesions
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Oral Cavity Cancer
Oropharyngeal Cancer
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: M.D. Anderson Cancer Center
First posted: 2018-06-13
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who receive care at the Avenue 360 Health and Wellness Clinic, a not for profit dental clinic in the Montrose area of Houston (a federally qualified health center).

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.


Eligibility 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
* 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

Primary outcomes:
measure: Number of participants for whom biopsy and CytID results both indicate presence of malignant or premalignant oral lesions
timeFrame: day 1 (at the time of oral examination)
measure: Number of participants for whom biopsy indicates presence of malignant or premalignant oral lesions and hpvID indicates presence of HPV
timeFrame: day 1 (at the time of oral examination)
measure: Number of participants for whom biopsy results, but not CytID results, indicate presence of malignant or premalignant oral lesions
timeFrame: day 1 (at the time of oral examination)
measure: Number of participants for whom CytID results, but not biopsy results, indicate presence of malignant or premalignant oral lesions
timeFrame: day 1 (at the time of oral examination)
measure: Number of participants for whom biopsy does not indicate presence of malignant or premalignant oral lesions, but hpvID indicates presence of HPV
timeFrame: day 1 (at the time of oral examination)
measure: Number of participants for whom biopsy indicates presence of malignant or premalignant oral lesions, but hpvID does not indicate presence of HPV
timeFrame: day 1 (at the time of oral examination)
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Clifton M Nichols, DDS
role: PRINCIPAL_INVESTIGATOR
References: