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

NCT06592716 | Active Not Recruiting

• 2 other identifiers: H-23071576p-2023-15163
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

HPV; HPV-DNA; Liquid biopsy; cell-free HPV-DNA; circulating HPV-DNA; circulating tumor HPV-DNA; ctHPV-DNA

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Time to recurrence by ctHPV-DNA

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

• Time to recurrence by clinical/radiological examination

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

• PET/CT

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

• Cancer fast-track referrals

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

• Fear of Recurrence Questionnaire

  at 2 months after treatment, and hereafter every 6 months for a minimum of 2 years, up to 3 years

Study Arms (1)

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

Interventions

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.

Identify recurrence

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Patients with newly diagnosed HPV+ (and/or p16+) oropharyngeal squamous cell carcinoma
• Above 18 years of age
• Informed consent

You may not qualify if:

• The patient does not speak or understand Danish
• patients recieving palliative treatment

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Copenhagen University Hospital, Denmark: collaborator

Study Sites (1)

Department of Otorhinolaryngology, Head and Neck Surgery and Audiology

Copenhagen, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Liquid biopsies, in form of blood samples from peripheral veins

MeSH Terms

Conditions

Oropharyngeal Neoplasms; Neoplasm Metastasis; Recurrence; Squamous Cell Carcinoma of Head and Neck

Interventions

Liquid Biopsy

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Investigative Techniques

Study Officials

• Christian von Buchwald, Professor, MD, DMSci

  Department of Otorhinolaryngology, Head and Neck Surgery and Audiology, Rigshospitalet

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Registrar, PhD, DMSci, Assistant Professor

Study Record Dates

• First Submitted: September 6, 2024
• First Posted: September 19, 2024
• Study Start: April 2, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)