HPV in Blood Samples From Cervical Cancer Patients. (NCT03749720) | Clinical Trial Compass
CompletedNot Applicable
HPV in Blood Samples From Cervical Cancer Patients.
Denmark141 participantsStarted 2018-06-15
Plain-language summary
By means of digital droplet PCR (ddPCR) anf targeted Next Generation Sequencing (NGS), 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.