The goal of this clinical trial is to determine the value of circulating tumour HPV DNA (human papilloma virus DNA found in the blood) at diagnosis, during treatment, and in the follow-up of patients diagnosed and treated for throat cancer caused by HPV.
The main question to answer is if the presence of HPV DNA in the blood one month after the treatment is useful in detecting remaining tumour or relapse within two years after treatment.
The participants will be asked to provide blood tests:
1. before treatment 2. weekly during the treatment 3. on all scheduled follow-up appointments 4. on all unplanned appointments where a relapse is suspected
Only patients with an HPV-positive primary tumour will eventually be eligible for inclusion.
Age >18 years.
Able to give informed consent.
The patient will be treated with curative intent.
None
The study population will consist of patients in the Southern Health Care Region of Sweden, referred to Skane University Hospital, Lund, Sweden for curative treatment of HPV-positive oropharyngeal cancer.
Cohort
Prospective
Blood sample
Diagnostic testBlood samples for analysis of circulating tumour HPVDNA
The sensitivity of detectable ctHPVDNA one month after (c)RT completion
To determine if detectable ctHPVDNA one month post (C)RT is useful to detect residual or recurrent tumours diagnosed within two years.
The correlation of ctHPVDNA with stage/tumour burden.
Analyse the possible correlation of ctHPVDNA with stage/tumour burden.
The correlation of ctHPVDNA titer decay during treatment with residual tumour.
Explore ctHPVDNA titer decay during the course of RT and surgery its relation to residual tumour evaluated at six months post treatment.
The correlation of ctHPVDNA levels with PET response and pathology reports for treatment evaluation.
Determine the additive value of ctHPVDNA in addition to PET response for treatment evaluation after (C)RT. The assessment will be performed at six months post treatment.
The negative predictive value (NPV) and positive predictive value (PPV) of ctHPVDNA in relation to locoregional and and metastatic recurrence.
Define the NPV and PPV of ctHPVDNA in relation to locoregional and metastatic recurrence diagnosed within three years after treatment completion.
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