Clinical trial · Interventional
HPV in Blood Samples From Cervical Cancer Patients.
Can Digital Droplet PCR (ddPCR) on Blood Samples From Patients With HPV Related Cancers Become a Reality in Cancer Treatment and Monitoring?
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HPV-Related Carcinoma | Human Papillomavirus-Related Carcinoma | ALIAS | 0.90 |
| HPV-Related Malignancy | Human Papillomavirus-Related Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood sample | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Cervical cancer patients
- description
- 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.
- interventionNames
- Other: Blood sample
Primary outcomes (1)
- measure
- HPV DNA
- timeFrame
- Two years
- description
- A qualitative and quantitative measure of HPV DNA in blood samples.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDBonlokke 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. PMID 41653072