HPV in Blood Samples From Cervical Cancer Patients.
HPV in Blood Samples From Cervical Cancer Patients.
By means of digital droplet PCR (ddPCR), this study examines blood samples from patients
 newly diagnosed with cervical cancer to investigate whether it is possible to measure the
 presence and amount of HPV DNA in these blood samples. The first blood sample is taken at
 time of diagnosis, and follow-up blood samples are collected during treatment- and follow-up
 visits. We expect to find a correlation between the disease stage and the viral load and also
 a decline in viral load after treatment. Furthermore, we hope that this method may serve as a
 way of detecting disease recurrence earlier than what is possible today.
This study hypothesises that in patients with HPV-related cervical cancer, HPV DNA may be
 released into the bloodstream from tumor cells. These fragments of HPV DNA shed by tumor may
 therefore be measured in blood samples from the patients. By using the same setting as for
 real-time PCR with PCR primers and probes for fluorescence detection, the study uses digital
 droplet PCR (ddPCR), a method based on dilution and partitioning of the blood sample in many
 reaction chambers or droplets, to measure absolute quantities of HPV DNA fragments in blood
 samples from women with different stages of cervical cancer. Patients are recruited at the
 time of diagnosis, where a baseline blood sample is collected. Follow-up blood samples are
 collected during treatment and at follow-up visits up to two years after the diagnosis. We
 expect the HPV DNA load to decrease after treatment, and if an increase in viral load is
 detected during follow-up, we expect this to be an early sign of a disease recurrence. The
 method may therefore become an effective monitoring tool in these patients in terms of
 detecting a ongoing disease recurrence, which gives us the chance to intervene and treat
 these patients before the disease becomes too disseminated.
Inclusion Criteria cases:

 -  Diagnosed with cervical cancer ≥ stage 1B between june 2018 and june 2020

 -  > 18 years of age at the time of diagnosis

 -  There must be available cervical tissue material from the patient to analyse for HPV

 Inclusion Criteria healthy controls

 -  Women > 18 years with no prior history of any cervical dysplasia

 Inclusion Criteria CIN3 controls

 -  Women > 18 years

 -  Must have a histologically verified severe cervical dysplasia (CIN3)

 -  Is admitted for cervical conisation

 Exclusion Criteria cases:

 -  < 18 years of age at time of cervical cancer diagnosis

 -  Cervical cancer < stage 1B

 Exclusion Criteria healthy controls:

 -  < 18 years of age

 -  Prior cervical dysplasia

 Exclusion Criteria CIN3 controls:

 -  < 18 years of age

 -  Women with only low grades of cervical dysplasia (CIN1 or CIN2)

 -  Women with HPV-negative cervical biopsies