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HPV in Blood Samples From Cervical Cancer Patients.

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.

Key Facts

Lead Sponsor

University of Aarhus

Enrollment

141

Start Date

2018-06-15

Completion Date

2022-10-30

Study Type

INTERVENTIONAL

Official Title

Can Digital Droplet PCR (ddPCR) on Blood Samples From Patients With HPV Related Cancers Become a Reality in Cancer Treatment and Monitoring?

Interventions

Blood sample

Conditions

HPV-Related CarcinomaHPV-Related Malignancy

Eligibility

Age Range

18 Years+

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

HPV DNA

A qualitative and quantitative measure of HPV DNA in blood samples.

Time frame: Two years

Locations

Department of Obstetrics and Gynecology, Aarhus, Denmark

Department of Obstetrics and Gynecolgy, Odense, Denmark

Linked Papers

Ultrasensitive next‐generation sequencing–based detection of circulating human papillomavirus DNA for cervical cancer recurrence monitoring

Abstract Background Circulating cell‐free human papillomavirus (ccfHPV) DNA is a promising biomarker for cervical cancer monitoring. This study used next‐generation sequencing (NGS) to assess its prognostic and surveillance value. Methods The authors included 141 cervical cancer patients (International Federation of Gynecology and Obstetrics IA1–IVB) grouped by treatment: primary surgery ( n = 50), primary surgery + adjuvant oncological ( n = 22), and primary oncological treatment ( n = 69). Plasma was collected pretreatment, at early follow‐up (first post‐treatment sample [FPS]), and during longer follow‐up. ccfHPV DNA was detected using an NGS‐based assay, enabling high sensitivity without prior knowledge of human papillomavirus (HPV) genotype. Associations between ccfHPV DNA status and recurrence were assessed using Cox proportional hazards models, and predictive accuracy was evaluated via sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV). Results Pretreatment ccfHPV DNA positivity was detected in 8.0%, 36.4%, and 82.6% of patients across the groups, and ccfHPV DNA positivity was significantly associated with higher recurrence risk (adjusted hazard ratio [HR], 4.92; 95% confidence interval [CI], 1.29–18.7; p = .02). At FPS, ccfHPV DNA positivity strongly predicted recurrence (adjusted HR, 19.1; 95% CI, 7.27–50.2), with a PPV of 83% and NPV of 90% for recurrence within 50 months. Among patients who developed recurrence, ccfHPV DNA was detectable before clinical evidence of recurrence in 60.9% of cases with a mean lead time of 144 days. Conclusion ccfHPV DNA detected by NGS is a strong prognostic biomarker for residual disease or recurrence. Its strong performance, already at early follow‐up, supports its integration into individualized follow‐up strategies. Prospective multicenter studies should validate these findings and guide clinical implementation. Trial Registration The study was registered with ClinicalTrials.gov (identifiers: NCT03749720)

Linked Investigators

Sara Bønløkke