Clinical trial · Observational
Exosome Testing as a Screening Modality for Human Papillomavirus-Positive Oropharyngeal Squamous Cell Carcinoma
An Observational, Single-Institution Pilot/Feasibility Study of Exosome Testing as a Screening Modality for Human Papillomavirus-Positive Oropharyngeal Squamous Cell Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Cancer of the oropharynx (middle, side and back walls of the throat; back of the tongue; soft palate, and tonsils), or oropharyngeal squamous cell carcinoma (OPSCC), has been on the rise in the United States. Human papillomavirus (HPV) has been recognized in many of these cancers, and testing for HPV has contributed to the higher reported rates of OPSCC. In this study, our goal is to develop a new test that can detect certain HPV proteins in the blood or saliva to help improve detection of OPSCC.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oropharyngeal Cancer | Malignant Oropharyngeal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (3)
- label
- Group 1: HPV-positive Cancer
- description
- Oropharyngeal cancer patients testing positive for human papillomavirus (HPV)
- label
- Group 2: HPV-positive Cancer
- description
- Oropharyngeal cancer patients who test positive for human papillomavirus (HPV)
- label
- Group 3: Healthy Controls
- description
- Patients with benign conditions
Primary outcomes (1)
- measure
- Cultured Cell Exosome Protein Signature Outcome Measure
- timeFrame
- 1 month
- description
- The presence of unique proteins obtained from primary cell cultures derived from HPV-OPSCC confirmed patients will be compared to normal tonsillar epithelial cells and established cell lines. The distribution of these protein signatures will be compared in HPV-OPSCC and normal epithelial cells.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria (Cancer Patients): * Male or Female * Age greater than or equal to 18 * Previously untreated, pathologically confirmed OPSCC (HPV+ or HPV-) * Ability to understand study information and provide written consent for participation. Inclusion Criteria (Non-cancer Patients): * Male or Female * Age greater than or equal to 18 * Ability to understand study information and provide written consent for participation Exclusion Criteria: * Age less than 18 years * Prisoners * Pregnant women * Patients with mental disability
References
Publications (0)
Data not yet available