Saliva Testing for High-Risk Human Papillomavirus Infection Oral Cavity and Pharynx Cancer (NCT06362421) | Clinical Trial Compass
WithdrawnNot Applicable
Saliva Testing for High-Risk Human Papillomavirus Infection Oral Cavity and Pharynx Cancer
Stopped: PI not moving forward with study at our institution
0Started 2025-08
Plain-language 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.
Who can participate
Age range
39 Years – 59 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants with Sensitivity for Detection of HPV 16, 18 and gene ACTB
Timeframe: Up to 2 years
2
Number of Participants with Specificity Detection of HPV 16, 18 and gene ACTB