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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03555721
Other study ID # HSC-GEN-17-1067
Secondary ID
Status Terminated
Phase
First received
Last updated
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
Health authority
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

Study Design


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)
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