NCT01984359

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Abramson Cancer Center at Penn Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

• Subjects With p16 Positive/HPV Positive Squamous Cell Carcinomas of the Oropharynx

Interventions

Type	Name	Description
OTHER	Obtaining Human tissue

Timeline

• Start date: 2013-05-01
• Primary completion: 2015-12-01
• Completion: 2018-05-24
• First posted: 2013-11-14
• Last updated: 2020-04-10

Locations

1 site across 1 country: United States