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

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

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 Overview

• Status: Active, not recruiting
• Conditions: Oropharynx Cancer; Oropharyngeal Carcinoma; Oropharynx Cancer, Recurrent; Oropharynx Cancer, Metastatic; Oropharyngeal Squamous Cell Carcinoma (OPSCC)
• Intervention / Treatment: Diagnostic test: Liquid biopsy

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark
    • Department of Otorhinolaryngology, Head and Neck Surgery and Audiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with HPV+ (and/or p16+) oropharyngeal squamous cell carcinoma

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Identify recurrence; The aim is to identify recurrence through longitudial analyses of circulating tumor HPV-DNA (ctHPV-DNA ) from blood samples.	Diagnostic test: Liquid biopsy; The intervention is a liquid biopsy as a blood sample taken in a peripheral vein. The blood samples are analyzed for ctHPV-DNA.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Collaborators: Copenhagen University Hospital, Denmark
• Investigators: Study Chair: Christian von Buchwald, Professor, MD, DMSci, Department of Otorhinolaryngology, Head and Neck Surgery and Audiology, Rigshospitalet

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: September 6, 2024
• First Submitted That Met QC Criteria: September 10, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): November 18, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Liquid biopsy; HPV; HPV-DNA; cell-free HPV-DNA; circulating HPV-DNA; circulating tumor HPV-DNA; ctHPV-DNA
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Pathologic Processes; Neoplasms by Site; Neoplasms; Disease Attributes; Neoplasms by Histologic Type; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Neoplastic Processes; Carcinoma; Otorhinolaryngologic Diseases; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Carcinoma, Squamous Cell; Pathological Conditions, Signs and Symptoms; Squamous Cell Carcinoma of Head and Neck; Recurrence; Neoplasm Metastasis; Oropharyngeal Neoplasms; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Cytological Techniques; Biopsy; Cytodiagnosis; Liquid Biopsy
• Other Study ID Numbers: H-23071576; p-2023-15163 (Other Identifier: Capital Region of Denmark)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No