Monitoring and Early Response Evaluation Using HPV DNA - A Study on Patients With HPV-posi
The goal of this clinical trial is to determine the value of circulating tumour HPV DNA (human papilloma virus DNA found in the blood) at diagnosis, during treatment, and in the follow-up of patients diagnosed and treated for throat cancer caused by HPV. The main question to answer is if the presence of HPV DNA in the
| Condition(s) | Oropharynx Squamous Cell Carcinoma |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | The goal of this clinical trial is to determine the value of circulating tumour HPV DNA (human papilloma virus DNA found in the blood) at diagnosis, during treatment, and in the follow-up of patients diagnosed and treated for throat cancer caused by HPV. The main question to answer is if the presence of HPV DNA in the blood one month after the treatment is useful in detecting remaining tumour or relapse within two years after treatment. The participants will be asked to provide blood tests: 1. before treatment 2. weekly during the treatment 3. on all scheduled follow-up appointments 4. on all unplanned appointments where a relapse is suspected |
| Who can participate | 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. |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Region Skane |
| Locations | Lund, Skåne County, Sweden |
| Start date | 2023-05-15 |
| NCT ID | NCT05649865 |
| Official listing | https://clinicaltrials.gov/study/NCT05649865 |