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.
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.
Study Type
OBSERVATIONAL
Collection of saliva samples and mouth swabs and pre-cancer dental evaluation by study staff. Unstimulated saliva will be collected then a buccal swab sample will be obtained. Participants will be asked to rinse their mouth with water, wait 10 minutes, then 1-2 mL of unstimulated saliva will be captured into sterile centrifuge tube. Next, a buccal swab sample will be collected using a sterile cotton swab and immediately placed in a transport tube containing buffer (Tris with low EDTA)
Collection of vital signs, medical history and current medications
Number of Participants with Sensitivity for Detection of HPV 16, 18 and gene ACTB
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.
Time frame: Up to 2 years
Number of Participants with Specificity Detection of HPV 16, 18 and gene ACTB
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.
Time frame: Up to 2 years
Overall Accuracy - All Participants
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.
Time frame: Up to 2 years
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Collection of saliva samples and mouth swab, complete oral medicine consultation by study staff. Unstimulated saliva will be collected then a buccal swab sample will be obtained. Participants will be asked to rinse their mouth with water, wait 10 minutes, then 1-2 mL of unstimulated saliva will be captured into sterile centrifuge tube. Next, a buccal swab sample will be collected using a sterile cotton swab and immediately placed in a transport tube containing buffer (Tris with low EDTA)