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| ID | Type | Description | Link |
|---|---|---|---|
| p-2023-15163 | Other Identifier | Capital Region of Denmark |
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| Name | Class |
|---|---|
| Copenhagen University Hospital, Denmark | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Identify recurrence | The aim is to identify recurrence through longitudial analyses of circulating tumor HPV-DNA (ctHPV-DNA ) from blood samples. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liquid biopsy | Diagnostic Test | The intervention is a liquid biopsy as a blood sample taken in a peripheral vein. The blood samples are analyzed for ctHPV-DNA. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and specificity of HPV ddPCR | Sensitivity and specificity of the ddPCR ctHPV-DNA test compared to clinically or radiologically verified recurrence. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to recurrence by ctHPV-DNA | Time to recurrence detected by ctHPV-DNA | From enrollment and for minimum 2 years, up to 3 years, after treatment |
| Time to recurrence by clinical/radiological examination |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with HPV+ (and/or p16+) oropharyngeal squamous cell carcinoma
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| Name | Affiliation | Role |
|---|---|---|
| Christian von Buchwald, Professor, MD, DMSci | Department of Otorhinolaryngology, Head and Neck Surgery and Audiology, Rigshospitalet | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Otorhinolaryngology, Head and Neck Surgery and Audiology | Copenhagen | Denmark |
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| ID | Term |
|---|---|
| D009959 | Oropharyngeal Neoplasms |
| D009362 | Neoplasm Metastasis |
| D012008 | Recurrence |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D000073890 | Liquid Biopsy |
| ID | Term |
|---|---|
| D001706 | Biopsy |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
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Liquid biopsies, in form of blood samples from peripheral veins
Time to recurrence detected by clinical or radiological examination
| From enrollment and for minimum 2 years, up to 3 years, after treatment |
| PET/CT | Number of PET/CT scans without detectable recurrence | 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. | 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 | at 2 months after treatment, and hereafter every 6 months for a minimum of 2 years, up to 3 years |
| D009369 | Neoplasms |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D019937 |
| Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D008919 | Investigative Techniques |