- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03749720
HPV in Blood Samples From Cervical Cancer Patients.
November 3, 2022 updated by: University of Aarhus
Can Digital Droplet PCR (ddPCR) on Blood Samples From Patients With HPV Related Cancers Become a Reality in Cancer Treatment and Monitoring?
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
141
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Aarhus, Denmark, 8200
- Department of Obstetrics and gynecology
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Odense, Denmark, 5000
- Department of Obstetrics and Gynecolgy
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Cervical cancer patients
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.
|
Blood sample taken from cervical cancer patients at time of diagnosis (baseline) and follow-up visits.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HPV DNA
Time Frame: Two years
|
A qualitative and quantitative measure of HPV DNA in blood samples.
|
Two years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sara Bønløkke, MD, Aarhus University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 15, 2018
Primary Completion (Actual)
October 30, 2022
Study Completion (Actual)
October 30, 2022
Study Registration Dates
First Submitted
November 19, 2018
First Submitted That Met QC Criteria
November 19, 2018
First Posted (Actual)
November 21, 2018
Study Record Updates
Last Update Posted (Actual)
November 8, 2022
Last Update Submitted That Met QC Criteria
November 3, 2022
Last Verified
September 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- U416
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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