Oropharyngeal Carcinoma, Oropharyngeal Squamous Cell Carcinoma (OPSCC), Oropharynx Cancer, Oropharynx Cancer, Metastatic, Oropharynx Cancer, Recurrent
Conditions
Keywords
HPV, HPV-DNA, Liquid biopsy, cell-free HPV-DNA, circulating HPV-DNA, circulating tumor HPV-DNA, ctHPV-DNA
Brief summary
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.
Interventions
DIAGNOSTIC_TESTLiquid biopsy
The intervention is a liquid biopsy as a blood sample taken in a peripheral vein. The blood samples are analyzed for ctHPV-DNA.
Sponsors
Copenhagen University Hospital, Denmark
Rigshospitalet, Denmark
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with newly diagnosed HPV+ (and/or p16+) oropharyngeal squamous cell carcinoma * Above 18 years of age * Informed consent
Exclusion criteria
* The patient does not speak or understand Danish * patients recieving palliative treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity and specificity of HPV ddPCR | 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. | Sensitivity and specificity of the ddPCR ctHPV-DNA test compared to clinically or radiologically verified recurrence. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to recurrence by ctHPV-DNA | From enrollment and for minimum 2 years, up to 3 years, after treatment | Time to recurrence detected by ctHPV-DNA |
| Time to recurrence by clinical/radiological examination | From enrollment and for minimum 2 years, up to 3 years, after treatment | Time to recurrence detected by clinical or radiological examination |
| PET/CT | From enrollment and for minimum 2 years, up to 3 years, after treatment | Number of PET/CT scans without detectable recurrence |
| Cancer fast-track referrals | From enrollment and for minimum 2 years, up to 3 years, after treatment | Number of referrals to Cancer Fast-track clinical investigations (conducted by an ENT specialist) without any detectable recurrences. |
| Fear of Recurrence Questionnaire | at 2 months after treatment, and hereafter every 6 months for a minimum of 2 years, up to 3 years | Quality of Life (QoL) will be evaluated by the Fear of Recurrence Questionnaire (short form) - filled out by patients during follow-up visits |
Countries
Denmark
Outcome results
None listed