HPV in Blood Samples From Cervical Cancer Patients.

Not Applicable

Completed

• Conditions: HPV-Related Carcinoma; HPV-Related Malignancy
• Interventions: Other: Blood sample

• Registration Number: NCT03749720
• Lead Sponsor: University of Aarhus

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2018-06-15
• Study First Submitted: 2018-11-19
• Study First Submitted QC: 2018-11-19
• Study First Posted: 2018-11-21
• Status Verified: 2021-09
• Primary Completion: 2022-10-30
• Study Completion: 2022-10-30
• Last Update Submitted: 2022-11-03
• Last Update Posted: 2022-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 141

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cervical cancer patients	Blood sample	Baseline- and follow-up blood samples are collected from the cervical cancer patients at time of diagnosis and during treatment and clinical follow-up. HPV DNA is measured in these samples.

Primary Outcome Measures

Name	Time	Method
HPV DNA	Two years	A qualitative and quantitative measure of HPV DNA in blood samples.

Trial Locations

Locations (2)

Department of Obstetrics and Gynecology; 🇩🇰 Aarhus, Denmark

Department of Obstetrics and Gynecolgy; 🇩🇰 Odense, Denmark