NCT05649865 Monitoring and Early Response Evaluation Using HPV DNA - A Study on Patients With HPV-positive Throat Cancer (MER-HPV)
| NCT ID | NCT05649865 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Region Skane |
| Condition | Oropharynx Squamous Cell Carcinoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2023-05-15 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2023-05-15 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Eligibility 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.
Contact & Investigator
Johanna Sjövall, MD,PhD
PRINCIPAL INVESTIGATOR
Dept. of clincial sciences, Lund University
Frequently Asked Questions
Who can join the NCT05649865 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Oropharynx Squamous Cell Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05649865 currently recruiting?
Yes, NCT05649865 is actively recruiting participants. Contact the research team at johanna.sjovall@med.lu.se for enrollment information.
Where is the NCT05649865 trial being conducted?
This trial is being conducted at Lund, Sweden.
Who is sponsoring the NCT05649865 clinical trial?
NCT05649865 is sponsored by Region Skane. The principal investigator is Johanna Sjövall, MD,PhD at Dept. of clincial sciences, Lund University. The trial plans to enroll 150 participants.