CytID Analysis of Oral Lesions

Oropharyngeal Cancer Clinical Trial

Official title:

CytID Analysis of Oral Lesions

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03555721
• Other study ID #: HSC-GEN-17-1067
• Status: Terminated
• Start date: May 30, 2018
• Est. completion date: November 1, 2022

Study information

• Verified date: May 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: November 1, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Mouth Neoplasms
• Oral Cavity Cancer
• Oropharyngeal Cancer
• Oropharyngeal Neoplasms

Intervention

Other:
• Oral examination with incandescent light
Suspicious oral lesions will be identified by oral examination with incandescent light.
• 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
• 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.
• 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.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)