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

Launched by WAKE FOREST UNIVERSITY HEALTH SCIENCES · Apr 8, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating whether saliva and oral swab samples can effectively detect human papillomavirus (HPV) in patients with a specific type of throat cancer called oropharyngeal squamous cell carcinoma. The goal is to develop and test new methods for identifying HPV in patients who have this cancer and compare the results with samples from healthy individuals.

To participate in the study, patients need to be between the ages of 39 and 59 and must have a confirmed diagnosis of oropharyngeal squamous cell carcinoma without having received any prior treatment. Healthy participants in the same age range are also welcome, as long as they have not had any history of cancer or active oral infections. If you choose to take part, you will provide saliva and oral swab samples, which will help researchers learn more about HPV and its connection to this type of cancer. Your participation could contribute to important advancements in cancer detection and treatment.

Gender

ALL

Eligibility criteria

• • 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.