Clinical trial · Observational
Saliva Testing for High-Risk Human Papillomavirus Infection Oral Cavity and Pharynx Cancer
Proof of Concept Assay Development of Point of Care Saliva Testing for High Risk-HPV Oral Cavity and Pharynx Cancers
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): PI not moving forward with study at our institution
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Human Papillomavirus Infection | — | UNRESOLVED | — |
| Oropharyngeal Squamous Cell Carcinoma | Oropharyngeal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oral Medicine Consultation Visit/Sample Collection | Genetic | — | UNRESOLVED |
| Pre-Radiation Dental Evaluation/Sample Collection | Genetic | — | UNRESOLVED |
| Pre-Study Visit | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Treatment naive patients with HPV+ OPSCC
- description
- Participants will receive a pre-study visit and pre-radiation dental evaluation.
- interventionNames
- Genetic: Pre-Radiation Dental Evaluation/Sample Collection
- Other: Pre-Study Visit
- label
- Control Group - Healthy subjects without cancer
- description
- Participants will receive a pre-study visit and oral medicine consultation visit.
- interventionNames
- Other: Pre-Study Visit
- Genetic: Oral Medicine Consultation Visit/Sample Collection
Primary outcomes (3)
- measure
- Number of Participants with Sensitivity for Detection of HPV 16, 18 and gene ACTB
- timeFrame
- Up to 2 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 39 Years
- Maximum age
- 59 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available