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

Not Applicable

Recruiting

• Conditions: Oropharyngeal Squamous Cell Carcinoma (SCC); Oropharynx Cancer; Oropharynx Cancer, Metastatic; Oropharynx Cancer, Recurrent; Oropharyngeal Carcinoma
• Interventions: Diagnostic Test: Liquid biopsy

• 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
• Status Verified: 2024-09
• Study First Submitted: 2024-09-06
• Study First Submitted QC: 2024-09-10
• Last Update Submitted: 2024-09-10
• Study First Posted: 2024-09-12
• Last Update Posted: 2024-09-12
• Primary Completion: 2028-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

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

Inclusion Criteria

• Patients with newly diagnosed HPV+ (or p16+) OPSCC carcinoma originating from the oropharynx
• Above 18 years of age
• Informed consent
• Patients offered curative treatment.

Exclusion Criteria

• The patient does not speak or understand Danish
• The patient has another disease/condition considered a reason for exclusion

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Identify recurrence	Liquid biopsy	The aim is to identify recurrence through longitudial analyses of cell-free HPV-DNA from blood samples.

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity of HPV ddPCR	At enrollment and at 2 months, 6 months, 12 months, 18 months, 24 months and 36 months after treatment or at suspicion of recurrence.	Sensitivity and specificity of the ddPCR HPV-test compared to clinically or radiologically verified recurrence.

Secondary Outcome Measures

Name	Time	Method
Time to recurrence by HPV-DNA	From enrollment to three years after treatment	Time to recurrence detected by circulating HPV-DNA
Time to recurrence by clinical/radiological examination	From enrollment to three years after treatment	Time to recurrence detected by clinical or radiological examination
PET/CT	From enrollment to three years after treatment	Number of PET/CT scans without detectable recurrence
Cancer fast-track referrals	From enrollment to three 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	After treatment at 2 months, 6 months, 12 months, 18 months, 24 months and 36 months	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