Clinical trial · Interventional
HPV Serum DNA Levels Predicting Outcome in p16+ Squamous Cell Head and Neck Cancer
A Pilot, Single-Center Study Of Quantitative HPV Serum Or Plasma DNA As A Prognostic Marker In P16+/HPV+ Squamous Carcinomas Of The Oropharynx And Unknown Primary Head And Neck Cancers
- 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)
To assess in an exploratory manner, the pronostic utility for locoregional control, progression-free and distant metastasis-free survival of a pre-therapy and post-therapy blood DNA test of HPV E6 and E7 DNA for subtypes 16 and 18 in p16+ and/or HPV+ oropharyngeal cancer patients. This will entail analysis of both initial pre-therapy HPV level as a continuous variable and initial post-therapy HPV level as a dichotomous variable.
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 |
|---|---|---|---|
| Subjects With p16 Positive/HPV Positive Squamous Cell Carcinomas of the Oropharynx | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Obtaining Human tissue | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Single arm
- description
- Biosamples will be obtained at multiple time-points for all participants
- interventionNames
- Other: Obtaining Human tissue
Primary outcomes (1)
- measure
- Number of subjects with Adverse Events
- timeFrame
- 4 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histoloically proven primary cancer of the oropharynx, p16(+) and/or HPV (+), who are planned for treatment with resection, radiation and/or chemotherapy. * Subsites of oropharynx:include tonsil, base of tongue, vallecula, oropharyngeal wall, soft palate, glossotonsillar sulcus. * No or minimal smoking history (\</= 10 pack-year, no smoking in the past 12 months last 10 years based on documented history and/or subject report) * Age 18 years or older * Subjects are capable of giving informed consent or have an acceptabl;e surrogate capable of giving consent on the subjects behalf. * Enrollment on any other study, regardless of therapy is allowed. * Enrollment on any other tumor or tissue banking study is allowed. * Patients who have had blood drawn as part of another study, including the IRB-approved ENT Tumor Bank Study, may be included in this study even if the patient has already had surgery. Exclusion Criteria: * Previous chemotherapy or radiation therapy to the head and neck unrelated to current disease. * Previous surgery for head and neck cancer unrelated to current disease. * Widespread , biopsy-proven metastatic disease (stage IVC disease) at time of presentation (small indeterminate lung or mediastinal nodules are allowed) * Patients who have started induction chemotherapy prior to consideration for study eligibility. * Another active cancer except nonmelanomatous skin cancer. * History of cervical penile or anal cancer. * Patient treated with surgery, adjuvant radiation therapy or chemotherapy outside of the University of Pennsylvania. * History of smoking in the past last 12 months 10 years * History of 10 pack-years of cigarette smoking based on documented history and/or subject report * Presence of sidespread leukoplakia or erythroplakia.
References
Publications (0)
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