Saliva Testing for High-Risk Human Papillomavirus Infection Oral Cavity and Pharynx Cancer
- Conditions
- Oropharyngeal Squamous Cell CarcinomaHuman Papillomavirus Infection
- Interventions
- Other: Pre-Study VisitGenetic: Pre-Radiation Dental Evaluation/Sample CollectionGenetic: Oral Medicine Consultation Visit/Sample Collection
- Registration Number
- NCT06362421
- Lead Sponsor
- Wake Forest University Health Sciences
- Brief Summary
The purpose of this research study is to determine if saliva and oral swab samples can be used to detect human papillomavirus in patients with cancer. In this study, the methods required to detect human papillomavirus will be developed and tested in samples collected from patients with oropharyngeal squamous cell carcinoma and compared to samples collected from participants without cancer.
- Detailed Description
To validate the detection of human papillomavirus 16 and 18 and reference gene ACTB in saliva and buccal swab samples obtained from patients with oropharyngeal squamous cell carcinoma (OPSCC) using the LAMP/CRISPR/electrochemical workflow.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 80
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Control Group - Healthy subjects without cancer Pre-Study Visit Participants will receive a pre-study visit and oral medicine consultation visit. Treatment naive patients with HPV+ OPSCC Pre-Study Visit Participants will receive a pre-study visit and pre-radiation dental evaluation. Control Group - Healthy subjects without cancer Oral Medicine Consultation Visit/Sample Collection Participants will receive a pre-study visit and oral medicine consultation visit. Treatment naive patients with HPV+ OPSCC Pre-Radiation Dental Evaluation/Sample Collection Participants will receive a pre-study visit and pre-radiation dental evaluation.
- Primary Outcome Measures
Name Time Method Number of Participants with Sensitivity for Detection of HPV 16, 18 and gene ACTB Up to 2 years The sensitivity of the LAMP/CRISPR/electrochemical workflow for detection of HPV 16, 18, and reference gene ACTB will be measured using patient samples with a 95% Clopper Pearson Exact Binomial confidence interval for the estimated sensitivity (or specificity) will have a lower bound of 83% if the observed sensitivity (or specificity) is 95%. For each of these estimates investigators will examine the proportion and the corresponding 95% Clopper Pearson exact binomial confidence interval.
Number of Participants with Specificity Detection of HPV 16, 18 and gene ACTB Up to 2 years The specificity of the LAMP/CRISPR/electrochemical workflow for detection of HPV 16, 18, and reference gene ACTB will be measured using patient samples with a 95% Clopper Pearson Exact Binomial confidence interval for the estimated sensitivity (or specificity) will have a lower bound of 83% if the observed sensitivity (or specificity) is 95%. For each of these estimates investigators will examine the proportion and the corresponding 95% Clopper Pearson exact binomial confidence interval.
Overall Accuracy - All Participants Up to 2 years For estimating overall accuracy (using all patients with n=80), the confidence interval will have a lower bound of 88% if the accuracy is at least 95%. For each of these estimates investigators will examine the proportion and the corresponding 95% Clopper Pearson exact binomial confidence interval.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Hayworth Cancer Center
🇺🇸High Point, North Carolina, United States
Atrium Health Wake Forest Baptist Comprehensive Cancer Center
🇺🇸Winston-Salem, North Carolina, United States