Oropharyngeal cancer, throat cancer throat cancer
Conditions
Interventions
niet van toepassing
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Any age 18 years or older; - Confirmed diagnosis of HPV-positive squamous cell carcinoma in the oropharynx (positive for p16 and/or HPV DNA); - Undergoing curative treatment and follow-up in one of the participating centers; - Being able to provide written informed consent;
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - In the case that inclusion was based solely on a positive result for p16, because HPV DNA results were unknown during inclusion, and it results that there is p16/HPV discordance (meaning positive for p16 and negative for HPV) these patients will be excluded. These patients won't be counted as part of the research population)- The presence of distant metastases at diagnosis, except for regional (cervical) lymph node metastases; - Any other known HPV-related malignancies (e.g. uterine cervix, anal, penile carcinomas); - Unable to provide written informed consent;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| of HPV DNA detection in blood plasma compared to standard clinical follow-up (including physical examination, usually with imaging) at 3-4 monthspost-treatment for the identification of residual tumor and/or tumor recurrences. | — |
Secondary
| Measure | Time frame |
|---|---|
| As a secondary parameter, we will evaluate the accuracy of multiple liquid biopsies over a 2-year follow-up period and assess the correlation betweenplasma HPV DNA levels and the development of tumor recurrences over time. Inaddition, we will determine the most accurate timing and frequency of blood collection moments in terms of recurrence prediction. Moreover, we will assess cost-effectiveness of liquid biopsies as a follow-up strategy. Patient characteristics that could correlate to HPV DNA plasma levels and may be a confounder for study results will also be collected, including; plasma HPV DNA levels at baseline (before treatment), gender, age, comorbidities, smoking status, alcohol consumption, HPV type, physical status, viral load, and clinical and pathological tumor characteristics. | — |
Countries
Netherlands
Contacts
Public ContactI Demers
Maastricht Universitair Medisch Centrum +
Outcome results
None listed