CytID Analysis of Oral Lesions

NCT03555721 | Terminated FDA Device

• 1 other identifier: HSC-GEN-17-1067
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Cavity Cancer; Oropharyngeal Cancer

Outcome Measures

Primary Outcomes (6)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

Study Arms (1)

Oral examination followed by biopsy, CytID, and hpvID

Identification of oral lesions with oral examination with both incandescent light and fluorescent light (OralID), and subsequent testing of suspicious oral lesions with biopsy, CytID, and hpvID

Other: Oral examination with incandescent light; Other: Oral examination with OralID; Diagnostic Test: Biopsy; Diagnostic Test: CytID; Diagnostic Test: hpvID

Interventions

Oral examination with incandescent light OTHER

Suspicious oral lesions will be identified by oral examination with incandescent light.

Oral examination followed by biopsy, CytID, and hpvID

Oral examination with OralID OTHER

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.

Oral examination followed by biopsy, CytID, and hpvID

Biopsy DIAGNOSTIC_TEST

Tissue will be collected to identify pre-cancerous or cancerous cells

Oral examination followed by biopsy, CytID, and hpvID

CytID DIAGNOSTIC_TEST

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.

Oral examination followed by biopsy, CytID, and hpvID

hpvID DIAGNOSTIC_TEST

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.

Oral examination followed by biopsy, CytID, and hpvID

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• M.D. Anderson Cancer Center: collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Mouth Neoplasms; Oropharyngeal Neoplasms

Interventions

Diagnosis, Oral; Biopsy

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Dentistry; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Clifton M Nichols, DDS

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: May 29, 2018
• First Posted: June 13, 2018
• Study Start: May 30, 2018
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: May 10, 2023

Record last verified: 2023-05

Locations

US (1)