Monitoring HPV DNA in patients with throat cancer
Analysis of HPV DNA in Plasma in Patients With HPV-positive Oropharyngeal Squamous Cell Carcinoma - a Prospective Study of HPV DNA Levels for Treatment Response and Surveillance
This study is testing if checking for HPV DNA in the blood of throat cancer patients can help doctors spot any remaining cancer or recurrences after treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Region Skane Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Lund, Skåne County) |
| Trial ID | NCT05649865 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the presence of circulating tumor HPV DNA in the blood of patients diagnosed with HPV-positive oropharyngeal squamous cell carcinoma. Participants will provide blood samples before treatment, weekly during treatment, and at all follow-up appointments to assess the potential of HPV DNA as a marker for treatment response and early detection of relapse. The study seeks to determine if the presence of HPV DNA one month post-treatment can help identify remaining tumors or recurrences within two years. By integrating HPV DNA analysis with traditional imaging techniques, the study hopes to improve patient outcomes through earlier detection of cancer recurrence.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years with an HPV-positive primary tumor undergoing curative treatment for oropharyngeal cancer.
Not a fit: Patients with a short life expectancy or those with psychiatric or addictive disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier detection of cancer recurrence, improving treatment outcomes for patients.
How similar studies have performed: Previous studies have shown promise in using circulating tumor HPV DNA as a marker for treatment response, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Only patients with an HPV-positive primary tumour will eventually be eligible for inclusion. Non-detectable ctHPVDNA at diagnosis will not be a reason for exclusion. 2. Age \>18 years. 3. Able to give informed consent. 4. The patient will be treated with curative intent. Exclusion Criteria: Patients with a short life expectancy, psychiatric or addictive disorders, or other medical conditions which might impair patient compliance may be excluded at the discretion of the investigator.
Where this trial is running
Lund, Skåne County
- Dept. of ORL-HNS — Lund, Skåne County, Sweden (Recruiting)
Study contacts
- Principal investigator: Johanna Sjövall, MD,PhD — Dept. of clincial sciences, Lund University
- Study coordinator: Johanna Sjövall, MD, PhD
- Email: johanna.sjovall@med.lu.se
- Phone: +4646172164
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.