CytID Analysis of Oral Lesions

Terminated

• Conditions: Oral Cavity Cancer; Oropharyngeal Cancer

• 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

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