HPV-Related CarcinomaNCT03749720
HPV in Blood Samples From Cervical Cancer Patients.
A study testing Blood sample in people with HPV-Related Carcinoma and HPV-Related Malignancy, run by University of Aarhus at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HPV-Related Carcinoma, HPV-Related Malignancy
- What is being tested?
- Blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 2 sitesDenmark
- Study dates
- 15 Jun 2018to 30 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Women > 18 years with no prior history of any cervical dysplasia
- Women > 18 years
- Must have a histologically verified severe cervical dysplasia (CIN3)
- Is admitted for cervical conisation
Who cannot join
- < 18 years of age at time of cervical cancer diagnosis
- Cervical cancer < stage 1B
- < 18 years of age
- Prior cervical dysplasia
- < 18 years of age
- Women with only low grades of cervical dysplasia (CIN1 or CIN2)
- Women with HPV-negative cervical biopsies
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Department of Obstetrics and Gynecology
Aarhus, 8200
Department of Obstetrics and Gynecolgy
Odense, 5000
About this study
Official title: 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) 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.
Read the 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. Furthermore, our research group has developed in-house amplicon-based Next Generation Sequencing (NGS) assays for HPV detection and genotyping (the NGS HPV genotyping panel) and HPV integration status and variants (the HPV16 panel), and blood samples are also analysed with the NGS HPV genotyping panel. Cervical tissue samples from primary tumor are collected and analysed with the NGS HPV genotyping panel, and HPV16 positives are further analysed with the NGS HPV16 panel. 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.
For included patients experiencing af recurrence of their disease, tissue samples from recurrent disease are collected and analysed with both the NGS HPV genotyping panel, the NGS HPV16 panel (for HPV16 positives), p16 staining, and a panel detecting relevant somatic mutations in the TP53 and RB1 tumor suppressor proteins.
- Conditions
- HPV-Related Carcinoma, HPV-Related Malignancy
- Being tested
- Blood sample
- Keywords
- Cervical Cancer, HPV, Pathology, ddPCR
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleOther
Blood sample taken from cervical cancer patients at time of diagnosis (baseline) and follow-up visits.
| Study group | Role | What they receive |
|---|---|---|
| Cervical cancer patients | Other | 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. Receives: Other: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
HPV DNA
A qualitative and quantitative measure of HPV DNA in blood samples.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2018
- Study start15 Jun 2018
- Primary completion30 Oct 2022
- Study completion30 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HPV-Related CarcinomaStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Case-control study with 141 case patients newly diagnosed cervical cancer and a control group of 10 healthy women with no prior cervical dysplasia and 25 women with cervical dysplasia (CIN3), respectively.
- Masking
- None (open label)
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sara Bønløkke, MD, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03749720
- Sponsor's protocol ID
- U416
- Status last verified
- Sep 2021
- First submitted
- 19 Nov 2018
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bonlokke S, Stougaard M, Sorensen BS, Parner E, Nyvang GB, Lindegaard JC, Blaakaer J, Bertelsen J, Fuglsang K, Steiniche T. Ultrasensitive next-generation sequencing-based detection of circulating human papillomavirus DNA for cervical cancer recurrence monitoring. Cancer. 2026 Feb 15;132(4):e70282. doi: 10.1002/cncr.70282.
PubMed 41653072
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Digital Droplet PCR (ddPCR) on Blood Samples From Patients With HPV Related Cancers Become a Reality in Cancer Treatment and Monitoring?
- ClinicalTrials.gov ID
- NCT03749720
- Acronym / sponsor ID
- U416
- Conditions
- HPV-Related Carcinoma, HPV-Related Malignancy
- Keywords
- Cervical Cancer, HPV, Pathology, ddPCR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 15 Jun 2018 (actual)
- Primary completion
- 30 Oct 2022 (actual)
- Study completion
- 30 Oct 2022 (actual)
- First posted
- 21 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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. Furthermore, our research group has developed in-house amplicon-based Next Generation Sequencing (NGS) assays for HPV detection and genotyping (the NGS HPV genotyping panel) and HPV integration status and variants (the HPV16 panel), and blood samples are also analysed with the NGS HPV genotyping panel. Cervical tissue samples from primary tumor are collected and analysed with the NGS HPV genotyping panel, and HPV16 positives are further analysed with the NGS HPV16 panel. 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.
For included patients experiencing af recurrence of their disease, tissue samples from recurrent disease are collected and analysed with both the NGS HPV genotyping panel, the NGS HPV16 panel (for HPV16 positives), p16 staining, and a panel detecting relevant somatic mutations in the TP53 and RB1 tumor suppressor proteins.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Case-control study with 141 case patients newly diagnosed cervical cancer and a control group of 10 healthy women with no prior cervical dysplasia and 25 women with cervical dysplasia (CIN3), respectively.
| Arm | Type | Receives |
|---|---|---|
| Cervical cancer patients | Other | Other: Blood sampleBaseline- 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
- Women > 18 years with no prior history of any cervical dysplasia
- Women > 18 years
Key exclusion criteria (7 listed)
- < 18 years of age at time of cervical cancer diagnosis
- Cervical cancer < stage 1B
- < 18 years of age
- Prior cervical dysplasia
- < 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampleBlood sample taken from cervical cancer patients at time of diagnosis (baseline) and follow-up visits. | Other | Cervical cancer patients |
Primary outcome
HPV DNA
Time frame: Two years
A qualitative and quantitative measure of HPV DNA in blood samples.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Derived from this study: PubMed 41653072Bonlokke S, Stougaard M, Sorensen BS, Parner E, Nyvang GB, Lindegaard JC, Blaakaer J, Bertelsen J, Fuglsang K, Steiniche T. Ultrasensitive next-generation sequencing-based detection of circulating human papillomavirus DNA for cervical cancer recurrence monitoring. Cancer. 2026 Feb 15;132(4):e70282. doi: 10.1002/cncr.70282.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Bønløkke, MD principal investigator
Aarhus University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample in people with HPV-Related Carcinoma and HPV-Related Malignancy, run by University of Aarhus at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HPV DNA (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03749720, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025; AzTrials last refreshed its copy on 7 Nov 2026.