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Active Not Recruiting
NCT04965792
Post-treatment Surveillance in HPV+ Oropharyngeal SCC
Conditions: HPV, Oropharyngeal Squamous Cell Carcinoma
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 150
Sponsor: Dana-Farber Cancer Institute
Location: Dana Farber Cancer Institute Boston Massachusetts
Summary
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.
Eligibility Criteria
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)
Source: ClinicalTrials.gov (NCT04965792). StuddyBuddy aggregates publicly available trial information.