Post-treatment Surveillance in HPV+ Oropharyngeal SCC

Study Overview
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Brief Summary
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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.

Detailed Description
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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 5 years. It is expected that about 150 people will take part in this research study.

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

Conditions
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Oropharyngeal Squamous Cell Carcinoma, HPV

Intervention / Treatment
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* Other: Screening


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HPV-positive oropharyngeal squamous cell carcinoma (HPV-OPC) Patients<br>Newly diagnosed HPV-positive oropharyngeal squamous cell carcinoma (HPV-OPC) patients will undergo blood testing for circulating tumor HPV DNA. | Other: Screening<br>* Blood test<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrent disease Rate | The proportion of patients with recurrence first detected by ctHPV DNA will be calculated as a percentage and 95% confidence intervals (CI) established using binomial exact calculation. | Up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence Detection Predictive Properties | Estimate positive and negative predictive value, sensitivity and specificity of ctHPV DNA for subsequent diagnosis of recurrent HPV-OPC | Time from first positive ctHPV DNA test to diagnosis of recurrence, assessed up to 5 years | 
| Time to diagnosis of recurrence | The median (IQR) number of months between the first positive ctHPV DNA test to definitive diagnosis of recurrence will be calculated. | Time from first positive ctHPV DNA test to confirmed diagnosis of recurrence, assessed up to 5 years | 
| Progression-free survival (PFS) | Calculated using Kaplan Meier method | Time from registration to the earlier of progression or death due to any cause, assessed up to 5 years | 
| Overall survival (OS) | Calculated using Kaplan Meier method | Time from registration to death due to any cause, or censored at date last known alive, assessed up to 5 years | 
| Quality of Life (QOL) | QOL will be evaluated using the by Fear of Recurrence Questionnaire-Short Form (score range 6-40; lower score is lower fear of recurrence) and EQ-5D-5L questionnaire (5 questions with score range 1-5 where higher score is worse; and one question with score range 0-100 where higher is better). | Pre-study, at 3 and 6 months, then at every other visit for the duration of the study up to 5 years | 
| Cost Comparison | Projected cost of ctHPV DNA-based compared with standard surveillance | Up to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HPV, Oropharyngeal Squamous Cell Carcinoma, HPV + Oropharyngeal Squamous Cell Carcinoma