Post-treatment Surveillance in HPV+ Oropharyngeal SCC

Circulating HPV DNA for Post-treatment Surveillance in HPV-positive Oropharyngeal Squamous Cell Carcinoma

In this research study the investigators are examining a blood test to detect HPV DNA in the blood that can possibly detect cancer recurrence earlier than with standard surveillance measures.

This research study involves blood tests to detect HPV DNA at regular time points after treatment for HPV-positive oropharyngeal squamous cell carcinoma (HPV-OPC). Participants may undergo scans based on the results of the blood tests. Study participants will also be asked to complete quality of life questionnaires periodically.

Participation in this study may last for up to 3 years. It is expected that about 150 people will take part in this research study.

Inclusion Criteria:

• Participants must have histologically or cytologically confirmed incident or recurrent squamous cell carcinoma of the tonsil or base of tongue (oropharynx) - includes biopsy of any lymph node with clinical evidence of an oropharynx tumor (unknown primary carcinoma in an involved cervical neck lymph node is permitted if high-risk HPV testing is positive on the involved node)
• HPV-associated tumor as defined by one or more : positive p16 immunohistochemistry (>70%) OR in situ hybridization OR PCR-based methods
• Age 18 years or older
• Will undergo oropharyngeal cancer treatment with curative intent
• Ability to understand and the willingness to sign a written informed consent document.
• Baseline positive or detectable ctHPV DNA result in plasma OR detectable corresponding HPV DNA in tumor tissue prior to treatment

Exclusion Criteria:

• Distant metastatic disease (M1, AJCC 8th edition)