Saliva Testing for High-Risk Human Papillomavirus Infection Oral Cavity and Pharynx Cancer

Human Papillomavirus Infection Clinical Trial

Official title:

Proof of Concept Assay Development of Point of Care Saliva Testing for High Risk-HPV Oral Cavity and Pharynx Cancers

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06362421
• Other study ID #: ONC-HN-2402
• Status: Not yet recruiting
• Start date: August 2024
• Est. completion date: August 2026

Study information

• Verified date: June 2024
• Source: Wake Forest University Health Sciences
• Contact: Study Coordinator
• Phone: 336-713-1790
• Email: cbynum[@]wakehealth.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: August 2026
• Est. primary completion date: August 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 39 Years to 59 Years

Eligibility

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.

Exclusion Criteria (Healthy Subjects)

• Previous diagnosis of cervical cancer or other cancers.

• Presence of known active oral infections of viral, fungal, or bacterial etiology except for gingivitis, periodontitis, or periapical abscess. Participants with known gingivitis, periodontitis, or periapical abscess are included.

Related Conditions & MeSH terms

• Human Papillomavirus Infection
• Infections
• Oropharyngeal Squamous Cell Carcinoma
• Papillomavirus Infections
• Pharyngeal Neoplasms
• Squamous Cell Carcinoma of Head and Neck

Intervention

Genetic:
• Pre-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)

Other:
• Pre-Study Visit
Collection of vital signs, medical history and current medications

Genetic:
• Oral 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)

Locations

Country	Name	City	State
United States	Hayworth Cancer Center	High Point	North Carolina
United States	Atrium Health Wake Forest Baptist Comprehensive Cancer Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	InnoTech Precision Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 2 years
Primary	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.	Up to 2 years
Primary	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.	Up to 2 years