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

July 28, 2025 updated by: Wake Forest University Health Sciences

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • High Point, North Carolina, United States, 27262
        • Hayworth Cancer Center
      • Winston-Salem, North Carolina, United States, 27157
        • Atrium Health Wake Forest Baptist Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The Head and Neck oncology team and navigators, as well as tumor board meetings, will be leveraged to identify and recruit newly diagnosed patients.

Participants in the healthy control group will be identified and recruited and enrolled after patients in the research cohort (those with OPSCC) participants have been enrolled.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Treatment naive patients with HPV+ OPSCC
Participants will receive a pre-study visit and pre-radiation dental evaluation.
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
Control Group - Healthy subjects without cancer
Participants will receive a pre-study visit and oral medicine consultation visit.
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Sensitivity for Detection of HPV 16, 18 and gene ACTB
Time Frame: 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.
Up to 2 years
Number of Participants with Specificity Detection of HPV 16, 18 and gene ACTB
Time Frame: 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.
Up to 2 years
Overall Accuracy - All Participants
Time Frame: 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.
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Collaborators

InnoTech Precision Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

April 8, 2024

First Submitted That Met QC Criteria

April 8, 2024

First Posted (Actual)

April 12, 2024

Study Record Updates

Last Update Posted (Actual)

July 31, 2025

Last Update Submitted That Met QC Criteria

July 28, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00115786
  • ONC-HN-2402 (Other Identifier: WFBCCC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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