Detecting cancer recurrence in the oropharynx using blood samples
Specificity and Sensitivity of Circulating HPV-DNA in Patients with Oropharyngeal Squamous Cell Carcinoma
This study is testing if blood samples can help find out early if HPV-positive throat cancer comes back in adults who have already been treated.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Locations | 1 site (Copenhagen) |
| Trial ID | NCT06592716 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of blood samples to analyze cell-free HPV-DNA as a method for detecting recurrence in patients who have been diagnosed and treated for HPV-positive oropharyngeal squamous cell carcinoma. By conducting longitudinal analyses, the researchers aim to determine if this liquid biopsy approach can provide early indications of cancer recurrence. The study focuses on patients who are above 18 years old and have consented to participate, specifically targeting those with newly diagnosed HPV+ oropharyngeal cancer.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with newly diagnosed HPV-positive oropharyngeal squamous cell carcinoma.
Not a fit: Patients who do not speak or understand Danish or those with other significant health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enable earlier detection of cancer recurrence, potentially improving patient outcomes and survival rates.
How similar studies have performed: While the use of liquid biopsies for cancer detection is an emerging field, this specific approach focusing on HPV-DNA in oropharyngeal cancer is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Copenhagen
- Department of Otorhinolaryngology, Head and Neck Surgery and Audiology — Copenhagen, Denmark (Recruiting)
Study contacts
- Study coordinator: Christian Grønhøj, MD, PhD, DMSci,
- Email: diagnostikiblod.rigshospitalet@regionh.dk
- Phone: +4535456863
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.