Actively Recruiting
Liquid Biopsies as a Tool for Monitoring Treatment and Early Recurrence in HPV-associated Diseases
Led by The Institute of Molecular and Translational Medicine, Czech Republic · Updated on 2026-02-12
480
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
T
The Institute of Molecular and Translational Medicine, Czech Republic
Lead Sponsor
N
National Institute for Cancer Research, Czech Republic
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of liquid biopsies to monitor treatment and detect early recurrence in cancers related to human papillomavirus (HPV), focusing on cervical cancer (CC) and oropharyngeal cancer (OPC). The study aims to find a sensitive and specific combination of sampling methods and biomarkers to identify patients at risk of disease returning, thereby improving care quality and reducing burden. The study includes two main groups: about 200 OPC patients (Arm A) and patients with CC or high-grade cervical lesions (Arm B). Each arm has prospective and retrospective parts. Samples taken include fresh tumor tissue before treatment and archived tissue afterward. Various liquid biopsies such as gargle lavage, oropharyngeal swabs, breath condensate, blood, and cervicovaginal swabs will be collected at set times before and after treatment and during follow-up for up to five years. Participants will provide samples regularly during follow-up visits, with HPV DNA and tumor mutation profiles monitored over time. The study tracks changes in circulating tumor HPV DNA and gene alterations to develop an algorithm predicting recurrence risk. The total observation period spans four years, during which clinical data and laboratory results are correlated to assess disease dynamics and treatment impact.
CONDITIONS
Brief Title
Role of Liquid Biopsies in HPV-associated Cancer Treatment Monitoring
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women diagnosed with cervical cancer (CC) or high-grade cervical intraepithelial lesions (HSIL)
- Men and women diagnosed with oropharyngeal cancer (OPC)
- Patients must agree to enroll and sign informed consent
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 4 weeks before treatment
Participants provide pre-treatment samples including fresh or archived tissue samples and liquid biopsies such as blood, gargle lavage, oropharyngeal swabs, breath condensate, or cervicovaginal swabs depending on cancer type for HPV detection and mutational analysis.
1 to 2 visits depending on sample collection
Duration - Up to 5 years post-treatment
Participants undergo regular collection of liquid biopsy samples post-treatment to monitor circulating tumor HPV DNA and HPV infection dynamics, along with clinical data correlation to detect early recurrence.
Visits every 3 months for 2 to 3 years, then every 6 months for 2 to 3 additional years depending on cancer type
Trial Site Locations
Total: 1 location
1
University Hospital Olomouc
Olomouc, Czechia, 77900
Actively Recruiting
Research Team
M
Marian Hajduch, MD., PhD.
V
Vladimira Koudelakova, MSc, Ph.D.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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