Saliva Testing for High-Risk Human Papillomavirus Infection Oral Cavity and Pharynx Cancer
Reason given: PI not moving forward with study at our institution
Trial details
- Who runs it
- Wake Forest University Health Sciences
- Trial code
- NCT06362421
- Record updated
- 31 July 2025
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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; Age 39 to 59 years; Ability to understand and the willingness to sign an IRB-approved informed consent document directly.
Exclusion: Patients with current or previous diagnosis with HPV+ infection status for cervical cancer or other cancers; Previous diagnosis of cervical cancer or other cancers; Patients with diagnoses of 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.