RecruitingNCT05649865

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


Sponsor

Region Skane

Enrollment

150 participants

Start Date

May 15, 2023

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria5

  • 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.

Exclusion Criteria1

  • 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.

Interventions

DIAGNOSTIC_TESTBlood sample

Blood samples for analysis of circulating tumour HPVDNA


Locations(1)

Dept. of ORL-HNS

Lund, Skåne County, Sweden

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