Human papillomavirus as a risk factor for the increase in incidence of tonsillar cancer.
Lalle Hammarstedt, David Lindquist, Hanna Dahlstrand...
https://pubmed.ncbi.nlm.nih.gov/16991119Actively Recruiting
Age: 18Years +
All Genders
ID05649865
Analysis of HPV DNA in Plasma in Patients With HPV-positive Oropharyngeal Squamous Cell Carcinoma for Treatment Response and Surveillance
Led by Region Skane · Updated on 2023-06-08
150
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying oropharyngeal squamous cell carcinoma caused by human papilloma virus (HPV), focusing on detecting HPV DNA in the blood of patients with HPV-positive throat cancer. The study aims to understand if measuring circulating tumour HPV DNA (ctHPVDNA) at diagnosis, during treatment, and follow-up can help identify remaining cancer or recurrence within two years after treatment. This observational study evaluates ctHPVDNA as an additional marker alongside standard PET-CT scans to improve treatment response assessment and early detection of relapse. Participants will provide blood samples for ctHPVDNA analysis before treatment, weekly during radiotherapy, and at scheduled follow-up visits up to five years. For surgically treated patients, blood samples will be collected on postoperative days 1 and 3, and weekly if adjuvant therapy is needed. The study involves comparison of ctHPVDNA levels with PET-CT results to guide evaluation after treatment and during surveillance, with additional tests ordered if ctHPVDNA levels increase. Throughout the study, participants will undergo regular blood draws and clinical reviews to monitor ctHPVDNA levels and disease status. Data collected includes clinical response, imaging results, recurrence, and survival status up to five years. The primary outcome is the sensitivity of detecting ctHPVDNA one month after treatment to predict residual or recurrent tumour. The study includes long-term follow-up and may inform future monitoring and surveillance strategies for HPV-positive throat cancer.
CONDITIONS
Brief Title
Monitoring and Early Response Evaluation Using HPV DNA - A Study on Patients With HPV-positive Throat Cancer (MER-HPV)
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients must have an HPV-positive primary tumour.
- Patients aged over 18 years.
- Ability to give informed consent.
- Planned treatment must be with curative intent.
You will not qualify if you...
- Patients with short life expectancy.
- Patients with psychiatric or addictive disorders that may impair compliance.
- Patients with other medical conditions that might affect study participation, at investigator discretion.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Before treatment initiation
Participants provide blood samples before treatment to analyze circulating tumour HPV DNA as a marker for treatment response.
1 visit (in-person)
Monitoring
Duration - During active treatment period (variable duration depending on treatment)
Participants provide blood samples weekly during radiotherapy or on postoperative days 1 and 3 if treated surgically, with additional weekly samples during any adjuvant (chemo)radiotherapy. This monitoring evaluates treatment response using circulating tumour HPV DNA levels.
Weekly visits for up to 7 weeks during radiotherapy or 2 visits in the first 3 days post-surgery plus weekly visits if adjuvant therapy is given
Surveillance
Duration - Up to 5 years post-treatment
Participants provide blood samples for circulating tumour HPV DNA analysis one month after treatment completion, then every three months for the first two years, and every six months during years two to five. This surveillance supports early detection of recurrence and aids follow-up assessments alongside scheduled clinical appointments.
Blood sample visits every 1 to 6 months aligned with follow-up appointments
Trial Site Locations
Total: 1 location
1
Dept. of ORL-HNS
Lund, Skåne County, Sweden, 22185
Actively Recruiting
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Research Team
J
Johanna Sjövall, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
The future of circulating tumor DNA as a biomarker in HPV related oropharyngeal squamous cell carcinoma.
Catherine T Haring, Sarah M Dermody, Pratyusha Yalamanchi...
https://pubmed.ncbi.nlm.nih.gov/35183912Plasma Circulating Tumor HPV DNA for the Surveillance of Cancer Recurrence in HPV-Associated Oropharyngeal Cancer.
Bhishamjit S Chera, Sunil Kumar, Colette Shen...
https://pubmed.ncbi.nlm.nih.gov/32017652Circulating HPV16 DNA may complement imaging assessment of early treatment efficacy in patients with HPV-positive oropharyngeal cancer.
Tomasz W Rutkowski, Agnieszka M Mazurek, Mirosław Śnietura...
https://pubmed.ncbi.nlm.nih.gov/32293457Circulating tumor HPV DNA complements PET-CT in guiding management after radiotherapy in HPV-related squamous cell carcinoma of the head and neck.
Hidenori Tanaka, Norihiko Takemoto, Masafumi Horie...
https://pubmed.ncbi.nlm.nih.gov/32895945Cell-free human papillomavirus DNA kinetics after surgery for human papillomavirus-associated oropharyngeal cancer.
Connor J O'Boyle, Giulia Siravegna, Shohreh Varmeh...
https://pubmed.ncbi.nlm.nih.gov/35139236Detectable Postoperative Circulating Tumor Human Papillomavirus DNA and Association with Recurrence in Patients With HPV-Associated Oropharyngeal Squamous Cell Carcinoma.
David M Routman, Sunil Kumar, Bisham S Chera...
https://pubmed.ncbi.nlm.nih.gov/35157995