NCT05649865Recruiting
Monitoring and Early Response Evaluation Using HPV DNA - A Study on Patients With HPV-positive Throat Cancer (MER-HPV)
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
Source: ClinicalTrials.gov · Last updated 8 Jun 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 150 (estimated)
- First submitted
- 17 Nov 2022
- Start date
- 15 May 2023
- Primary completion date
- May 2027
- Lead sponsor
- Region Skane
- Diseases
- Head and neck cancer
- NCT number
- NCT05649865
What you commit to
- Study type: Observational
- Planned participants: 150
- From 15 May 2023 to the primary completion date, May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Who the study is looking for
- 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.
- Age \>18 years.
- Able to give informed consent.
- The patient will be treated with curative intent.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dept. of ORL-HNS Coordinator of this site? Confirm its status | Lund | Sweden | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.