LCCC 2044: Prospective Observational Study to Validate Circulating HPVDNA and Prognostic Genomic Biomarkers in HPV-associated OPSCC

Primary

• Recurrence of OPSCC

  Patients will undergo post-treatment CT scans per institutional standard of care to detect cancer recurrence. Status of recurrence of OPSCC will be confirmed based on biopsy.

  Time frame: From date of therapy completion until biopsy-proven recurrence, assessed up to 5 years

• Progression-free survival

  Time-to-recurrence will be defined as time lapsed from end (or start) of treatment to first date recurrence (biopsy proven occur later) is detected by CT scans, or death. Otherwise, time-to-recurrence is censored at end of study date.

  Time frame: From beginning or end of treatment until date of CT-detected recurrence or date of death, assessed up to 5 years

• Positive Predictive Value

  Positive Predictive Value (PPV) is defined as probability that patients with two consecutive positive cHPVDNA (i.e., detectable cHPVDNA) really develop OPSCC recurrence during the study period.

  Time frame: Baseline to up to 5 years

• Negative Predictive Value

  Negative Predictive Value (NPV) is defined as probability that patients without two consecutive positive cHPVDNA do not develop OPSCC recurrence during the study period.

  Time frame: Baseline to up to 5 years

• Quality of Life questionnaire

  At specified timepoints before, during, and after treatment, patients will complete a questionnaire comprised of questions from the European Organization for Research and Treatment of Cancer (EORTC) QLQ H\&N35, which is for head and neck cancer patients, and EORTC QLQ C30, which is a general cancer assessment.

  Time frame: Baseline until recurrence or up to 5 years