NCT05904327

Circulating Biomarkers in Oropharyngeal Cancers

The Use of Circulating Biomarkers in Oropharyngeal Cancer and Unknown Primary of Head and Neck - a Prospective Multicenter Study for Treatment Evaluation and Surveillance

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 130 (actual)
• Sponsor: Region Örebro County · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The goal of this observational longitudinal study is to learn about circulating tumor Human Papilloma Virus-DNA (ctHPV-DNA) as a biomarker for HPV positive oropharyngeal cancer and cancer of unknown primary of the head and neck. The main questions it aims to answer are: * Can ctHPV-DNA be used for treatment evaluation in HPV positive oropharyngeal cancer and cancer of unknown primary of the head and neck? * Can circulating HPV-DNA be used as a biomarker for recurrent disease during surveillance? Participants will be asked to leave plasma samples at diagnose, at the end of treatment and at every clinical follow-up. The patients are there own controls.

Detailed description

In the multicenter study of CIRCOS, Circulating biomarkers in oropharyngeal cancer, patients with oropharyngeal cancer or cancer of unknown primary of the head and neck are consecutively included. Plasma samples are collected at diagnosis, at the end of treatment and during surveillance after treatment. At diagnose participants will fill in informed consent and a form regarding known risk factors for cancer. Tissue from the tumor will be analyzed for HPV genotype with a multiplex q-PCR. Information about p16 will be collected from medical records. ctHPV-DNA are short DNA fragments that leaks into the blood stream from tumor cells during apoptosis and necrosis. In the study, ctHPV-DNA will be extracted from blood plasma. Levels of ctHPV-DNA (copies/mL) will be measured using digital droplet PCR (ddPCR) with genotype specific assays (based on the result of q-PCR at diagnose) used in singleplex (SAGA diagnostics). A negative sample after treatment will be defined as a good molecular response for evaluation after treatment. Two consecutive, positive samples during surveillance will be defined as molecular recurrence. If a molecular recurrence is seen patients will be contacted and offered an extra clinical control at an Ear nose and throat department. If a patient is HPV negative in tissue, the tissue will be analyzed with whole genome sequencing. If a mutation is found, a personalized ddPCR-kit will be used for plasma. All patients will be followed for five years.

Conditions

• Oropharynx Squamous Cell Carcinoma
• Oropharynx Cancer
• Tonsillar Cancer
• Base of the Tongue Carcinoma

Timeline

• Start date: 2020-12-01
• Primary completion: 2028-03-31
• Completion: 2028-03-31
• First posted: 2023-06-15
• Last updated: 2023-06-15

Locations

1 site across 1 country: Sweden