Human Papillomavirus Infection, Oropharyngeal Squamous Cell Carcinoma
Conditions
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.
Interventions
GENETICPre-Radiation Dental Evaluation/Sample Collection
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)
OTHERPre-Study Visit
Collection of vital signs, medical history and current medications
GENETICOral Medicine Consultation Visit/Sample Collection
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)
Sponsors
InnoTech Precision Medicine
Wake Forest University Health Sciences
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
39 Years to 59 Years
Healthy volunteers
Yes
Inclusion criteria
(Patients with Cancer); * Patients must have histologically confirmed oropharyngeal squamous cell carcinoma without prior treatment. A pathology report should be referenced/available. * Patients with p16 positive oropharyngeal squamous cell carcinoma. * Age 39 to 59 years. * Ability to understand and the willingness to sign an IRB-approved informed consent document directly. Inclusion Criteria (Healthy Subjects) * Age 39 to 59 years. * Ability to understand and the willingness to sign an IRB-approved informed consent document directly.
Exclusion criteria
(Patients with Cancer) * Patients with diagnoses of other cancers. * Patients with current or previous diagnosis with HPV+ infection status for cervical cancer or other cancers.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Outcome results
None listed