HPV, Oropharyngeal Squamous Cell Carcinoma
Conditions
Keywords
HPV, Oropharyngeal Squamous Cell Carcinoma, HPV + Oropharyngeal Squamous Cell Carcinoma
Brief 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.
Detailed description
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.
Interventions
OTHERScreening
Blood test
Sponsors
Dana-Farber Cancer Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrent disease Rate | Up to 5 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence Detection Predictive Properties | Time from first positive ctHPV DNA test to diagnosis of recurrence, assessed up to 5 years | Estimate positive and negative predictive value, sensitivity and specificity of ctHPV DNA for subsequent diagnosis of recurrent HPV-OPC |
| Time to diagnosis of recurrence | Time from first positive ctHPV DNA test to confirmed diagnosis of recurrence, assessed up to 5 years | The median (IQR) number of months between the first positive ctHPV DNA test to definitive diagnosis of recurrence will be calculated. |
| Progression-free survival (PFS) | Time from registration to the earlier of progression or death due to any cause, assessed up to 5 years | Calculated using Kaplan Meier method |
| Overall survival (OS) | Time from registration to death due to any cause, or censored at date last known alive, assessed up to 5 years | Calculated using Kaplan Meier method |
| Quality of Life (QOL) | Pre-study, at 3 and 6 months, then at every other visit for the duration of the study up to 5 years | 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). |
| Cost Comparison | Up to 5 years | Projected cost of ctHPV DNA-based compared with standard surveillance |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATOREleni M Rettig, MD
Brigham and Women's Hospital
Outcome results
None listed