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NCT Number: NCT06592716

Can Recurrence of Cancer in the Oropharynx be Detected by Blood Samples?

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Oropharynx Cancer Carcinoma Carcinoma, Squamous Cell Disease Attributes Head and Neck Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplastic Processes Oropharyngeal Carcinoma Oropharyngeal Neoplasms Oropharyngeal Squamous Cell Carcinoma (OPSCC) Oropharynx Cancer, Metastatic Oropharynx Cancer, Recurrent Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Pharyngeal Diseases Pharyngeal Neoplasms Recurrence Squamous Cell Carcinoma of Head and Neck Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Otorhinolaryngology, Head and Neck Surgery and Audiology

Copenhagen, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Sensitivity and specificity of HPV ddPCR

    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.

    Sensitivity and specificity of the ddPCR ctHPV-DNA test compared to clinically or radiologically verified recurrence.

Secondary outcomes

  1. Time to recurrence by ctHPV-DNA

    Time frame: From enrollment and for minimum 2 years, up to 3 years, after treatment

    Time to recurrence detected by ctHPV-DNA

  2. Time to recurrence by clinical/radiological examination

    Time frame: From enrollment and for minimum 2 years, up to 3 years, after treatment

    Time to recurrence detected by clinical or radiological examination

  3. PET/CT

    Time frame: From enrollment and for minimum 2 years, up to 3 years, after treatment

    Number of PET/CT scans without detectable recurrence

  4. Cancer fast-track referrals

    Time frame: 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.

  5. Fear of Recurrence Questionnaire

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Copenhagen University Hospital, Denmark

Registry information

Official study title

Specificity and Sensitivity of Circulating HPV-DNA in Patients With Oropharyngeal Squamous Cell Carcinoma

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Sep 19, 2024
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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