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CytID Analysis of Oral Lesions

NCT03555721 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 18

Last updated 2023-05-10

No results posted yet for this study

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.

Conditions

  • Oral Cavity Cancer
  • Oropharyngeal Cancer

Interventions

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.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    collaborator OTHER

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Clifton M Nichols, DDS · The University of Texas Health Science Center, Houston

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-05-30
Primary Completion
2022-11-01
Completion
2022-11-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03555721 on ClinicalTrials.gov