This study investigates if longitudinal analyses of cell-free HPV-DNA in blood samples can be utilized to detect recurrence in patients diagnosed and treated for HPV-positive oropharyngeal squamous cell carcinoma.
Study Type
OBSERVATIONAL
Enrollment
200
The intervention is a liquid biopsy as a blood sample taken in a peripheral vein. The blood samples are analyzed for ctHPV-DNA.
Department of Otorhinolaryngology, Head and Neck Surgery and Audiology
Copenhagen, Denmark
Sensitivity and specificity of HPV ddPCR
Sensitivity and specificity of the ddPCR ctHPV-DNA test compared to clinically or radiologically verified recurrence.
Time frame: At enrollment and at 2 months after end treatment, and hereafter every 6 month for a minimum of 2 years, up to 3 years, or at suspicion of recurrence.
Time to recurrence by ctHPV-DNA
Time to recurrence detected by ctHPV-DNA
Time frame: From enrollment and for minimum 2 years, up to 3 years, after treatment
Time to recurrence by clinical/radiological examination
Time to recurrence detected by clinical or radiological examination
Time frame: From enrollment and for minimum 2 years, up to 3 years, after treatment
PET/CT
Number of PET/CT scans without detectable recurrence
Time frame: From enrollment and for minimum 2 years, up to 3 years, after treatment
Cancer fast-track referrals
Number of referrals to Cancer Fast-track clinical investigations (conducted by an ENT specialist) without any detectable recurrences.
Time frame: From enrollment and for minimum 2 years, up to 3 years, after treatment
Fear of Recurrence Questionnaire
Quality of Life (QoL) will be evaluated by the Fear of Recurrence Questionnaire (short form) - filled out by patients during follow-up visits
Time frame: at 2 months after treatment, and hereafter every 6 months for a minimum of 2 years, up to 3 years
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