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

Not Applicable

Active, not recruiting

• Conditions: Oropharynx Cancer; Oropharynx Cancer, Metastatic; Oropharynx Cancer, Recurrent; Oropharyngeal Carcinoma; Oropharyngeal Squamous Cell Carcinoma (OPSCC)

• Registration Number: NCT06592716
• Lead Sponsor: Rigshospitalet, Denmark

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-02
• Study First Submitted: 2024-09-06
• Study First Submitted QC: 2024-09-10
• Study First Posted: 2024-09-19
• Status Verified: 2025-11
• Last Update Submitted: 2025-11-14
• Last Update Posted: 2025-11-18
• Primary Completion: 2028-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Otorhinolaryngology, Head and Neck Surgery and Audiology; 🇩🇰 Copenhagen, Denmark