Post-treatment Surveillance in HPV+ Oropharyngeal SCC

Running, not enrolling

Conditions studied: HPV, Oropharyngeal Squamous Cell Carcinoma

In brief

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.

Key facts

Study ID

NCT04965792

Run by

Dana-Farber Cancer Institute

People needed

150

Starts

2020-11-19

Expected to finish

2027-11-01

Last updated by the study team

2026-06-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• Dana Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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