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NCT Number: NCT05774561

Role of Liquid Biopsies in HPV-associated Cancer Treatment Monitoring

This trial will evaluate the possible benefits and the performance of liquid biopsies in HPV-associated cancer treatment monitoring. This study aims to find a combination of an adequately sensitive and specific sampling method and biomarkers for early risk stratification of disease recurrence.

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Key information

Conditions

Cervical Cancer Cervical Dysplasia Communicable Diseases DNA Virus Infections Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Head and Neck Neoplasms Human Papillomavirus Infection Infections Neoplasms Neoplasms by Site Oropharyngeal Cancer Oropharyngeal Neoplasms Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pharyngeal Diseases Pharyngeal Neoplasms Precancerous Conditions Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Stomatognathic Diseases Tumor Virus Infections Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Dysplasia Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Virus Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Olomouc

Olomouc, 77900, Czechia

Location status: Recruiting

About this study

Although the cancers associated with human papillomavirus (HPV) infection are currently almost entirely preventable, a significant part of the Czech population suffers from these diseases. The most common HPV-associated cancers are cervical cancer (CC) and oropharyngeal cancer (OPC). In these, the severe problem is successful monitoring of the treatment effectiveness and early disease recurrence detection. It is, therefore, necessary to find a non-invasive method that could specifically and timely identify patients at risk of recurrence and thus enable patients with quality and less burdensome medical care. The use of liquid biopsies (LB), which the study focuses on, looks most promising.

This study is divided into two arms, with each arm including both prospective and retrospective parts. Into prospective parts will be enrolled only newly diagnosed CC/HSIL (high-grade cervical intraepithelial lesions) or OPC patients. In contrast, the retrospective part will enroll patients in post-treatment follow-up. In both study arms, fresh tumor tissues will be sampled from patients in prospective parts before treatment, and archived Formalin Fixed Paraffin Embedded (FFPE) tissue samples will be obtained from patients of retrospective parts.

Regarding the liquid biopsies, pre & post-treatment sampling of LB will be performed. Subsequently, regular sample acquisition will be performed during follow-up according to the standard medical practice in both prospective and retrospective parts. Oropharyngeal swabs, gargle lavage,exhaled breath condensate (EBC), and blood samples will be collected from OPC patients. Blood collection and self-sampling of cervicovaginal swabs will be performed in patients with CC/HSIL. All samples, excluding blood samples, will be tested for the presence of the most prevalent high-risk and low-risk HPV genotypes. The circulating tumor (ct) HPV DNA will be monitored in blood samples. Additionally, the mutation profile of the primary tumors will be examined in fresh and FFPE samples.

The dynamics of HPV DNA will be monitored throughout all follow-up samples and correlated with the obtained clinical data. A created panel of frequently altered genes will be used for alterations monitoring in liquid biopsies. In the final analysis of laboratory and clinical results, we assume a finding of a clinically usable algorithm that could predict the risk of disease recurrence for a particular patient.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Women diagnosed with CC/HSIL. Men and women diagnosed with OPC. Patients must agree with study enrollment and must sign study informed consent.

Exclusion criteria

No exclusion criteria are set.

Treatment and study plan

Arm A - Diagnostic test: HPV detection in liquid biopsies

Diagnostic Test

Patients will be asked to perform self-collection of gargle lavage samples. Oropharyngeal swabs, breath condensate, and blood samples will be taken by trained clinicians.

Arm B - Diagnostic test: HPV detection in liquid biopsies

Diagnostic Test

Patients will be asked to perform cervicovaginal self-sampling using Evalyn Brush. Blood samples will be taken by trained clinicians.

Primary outcomes

  1. Dynamics of HPV infection in cervical cancer patients during 4-year follow-up.

    Time frame: 4 years

    HPV-status in liquid biopsies collected during pre-treatment, post-treatment and follow-up check-ups.

  2. Dynamics of HPV infection in oropharyngeal cancer patients during 4-year follow-up.

    Time frame: 4 years

    HPV-status in liquid biopsies collected during pre-treatment, post-treatment and follow-up check-ups.

  3. Dynamics of circulating tumor (ct) HPV DNA in oropharyngeal cancer patients.

    Time frame: 4 years

    Correlation of plasmatic ct HPV DNA level with cancer patient´s prognosis.

  4. Dynamics of circulating tumor (ct) HPV DNA in cervical cancer patients

    Time frame: 4 years

    Correlation of plasmatic ct HPV DNA level with patient´s prognosis

  5. Analysis of the mutational landscape of oropharyngeal cancer cases.

    Time frame: 4 years

    Correlation of tumor mutational burden (TMB) with cancer patient´s prognosis.

  6. Analysis of the mutational landscape of cervical cancer cases.

    Time frame: 4 years

    Correlation of tumor mutational burden (TMB) with cancer patient´s prognosis.

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

The Institute of Molecular and Translational Medicine, Czech Republic

Other

Collaborators

  • National Institute for Cancer Research, Czech Republic
  • University Hospital Olomouc

Registry information

Official study title

Liquid Biopsies - a Possible Tool for Treatment Monitoring and Early Recurrence Detection in HPV-associated Diseases

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Mar 17, 2023
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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