Role of Liquid Biopsies in HPV-associated Cancer Treatment Monitoring
Liquid Biopsies - a Possible Tool for Treatment Monitoring and Early Recurrence Detection in HPV-associated Diseases
1 other identifier
observational
480
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2022
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2022
CompletedFirst Submitted
Initial submission to the registry
January 24, 2023
CompletedFirst Posted
Study publicly available on registry
March 17, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
February 12, 2026
July 1, 2025
4 years
January 24, 2023
February 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Dynamics of HPV infection in cervical cancer patients during 4-year follow-up.
HPV-status in liquid biopsies collected during pre-treatment, post-treatment and follow-up check-ups.
4 years
Dynamics of HPV infection in oropharyngeal cancer patients during 4-year follow-up.
HPV-status in liquid biopsies collected during pre-treatment, post-treatment and follow-up check-ups.
4 years
Dynamics of circulating tumor (ct) HPV DNA in oropharyngeal cancer patients.
Correlation of plasmatic ct HPV DNA level with cancer patient´s prognosis.
4 years
Dynamics of circulating tumor (ct) HPV DNA in cervical cancer patients
Correlation of plasmatic ct HPV DNA level with patient´s prognosis
4 years
Analysis of the mutational landscape of oropharyngeal cancer cases.
Correlation of tumor mutational burden (TMB) with cancer patient´s prognosis.
4 years
Analysis of the mutational landscape of cervical cancer cases.
Correlation of tumor mutational burden (TMB) with cancer patient´s prognosis.
4 years
Study Arms (2)
Arm A - Oropharyngeal cancer patients
In total, approx. 200 OPC cancer patients will be enrolled in the study Arm A, with both prospective and retrospective parts enrolling 100 OPC patients. The Arm A will enroll patients from the Department of Otorhinolaryngology and Head and Neck Surgery, University Hospital Olomouc. Pre-treatment primary samples of fresh or FFPE tissue samples will be collected. Liquid biopsies (gargle lavage, oropharyngeal smear, breath condensate, and blood sample) will be collected. Obtained samples will be tested by CE-IVD (device complies with European in vitro diagnostic Directive) marked HPV diagnostic test. A laboratory developed digital droplet PCR assay will be used for ct HPV DNA detection. Sampling will be performed at pre \& post treatment check-ups, and every 3 months for 3 years and every 6 months for 2 years.
Arm B - Cervical cancer patients
Into the study Arm B will be enrolled 80 patients with CC and 120 patients with HSIL, and 80 patients will be enrolled into the retrospective part. The Arm B will enroll patients from the Department of Gynecology and Obstetrics, University Hospital Olomouc. Pre-treatment primary samples of fresh or FFPE tissue samples will be collected. Liquid biopsies (cervicovaginal swab and blood sample) will be collected. Obtained samples will be tested by CE-IVD marked HPV diagnostic test. A laboratory developed digital droplet PCR assay will be used for ct HPV DNA detection. Sampling will be performed at pre \& post treatment check-ups, and every 3 months for 2 years and every 6 months for 3 years.
Interventions
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.
Patients will be asked to perform cervicovaginal self-sampling using Evalyn Brush. Blood samples will be taken by trained clinicians.
Eligibility Criteria
Oropharyngeal cancer patients, Cervical cancer patients
You may qualify if:
- Women diagnosed with CC/HSIL. Men and women diagnosed with OPC. Patients must agree with study enrollment and must sign study informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Olomouc
Olomouc, 77900, Czechia
Biospecimen
gargle lavage samples, oropharyngeal swabs, breath condensate, blood samples
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Marian Hajduch, MD., PhD.
IMTM, Palacky University in Olomouc, Faculty of Medicine and Dentistry
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 24, 2023
First Posted
March 17, 2023
Study Start
June 1, 2022
Primary Completion (Estimated)
May 31, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
February 12, 2026
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share