CytID Analysis of Oral Lesions

Terminated

• Conditions: Oral Cavity Cancer; Oropharyngeal Cancer
• Interventions: Other: Oral examination with incandescent light; Other: Oral examination with OralID; Diagnostic Test: Biopsy; Diagnostic Test: CytID; Diagnostic Test: hpvID

• Registration Number: NCT03555721
• Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-29
• Study Start: 2018-05-30
• Study First Submitted QC: 2018-06-12
• Study First Posted: 2018-06-13
• Primary Completion: 2022-11-01
• Study Completion: 2022-11-01
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-08
• Last Update Posted: 2023-05-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 18

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Oral examination followed by biopsy, CytID, and hpvID	Oral examination with OralID	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
Oral examination followed by biopsy, CytID, and hpvID	Biopsy	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
Oral examination followed by biopsy, CytID, and hpvID	CytID	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
Oral examination followed by biopsy, CytID, and hpvID	Oral examination with incandescent light	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
Oral examination followed by biopsy, CytID, and hpvID	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

Primary Outcome Measures

Name	Time	Method
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 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)
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)

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States