Arm A - Diagnostic test: HPV detection in liquid biopsiesArm B - Diagnostic test: HPV detection in liquid biopsies
Arm A - Diagnostic test: HPV detection in liquid biopsies: 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: Patients will be asked to perform cervicovaginal self-sampling using Evalyn Brush. Blood samples will be taken by trained clinicians.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Dynamics of HPV infection in cervical cancer patients during 4-year follow-up. — 4 years HPV-status in liquid biopsies collected during pre-treatment, post-treatment and follow-up check-ups.
Dynamics of HPV infection in oropharyngeal cancer patients during 4-year follow-up. — 4 years HPV-status in liquid biopsies collected during pre-treatment, post-treatment and follow-up check-ups.
Dynamics of circulating tumor (ct) HPV DNA in oropharyngeal cancer patients. — 4 years Correlation of plasmatic ct HPV DNA level with cancer patient´s prognosis.
Dynamics of circulating tumor (ct) HPV DNA in cervical cancer patients — 4 years Correlation of plasmatic ct HPV DNA level with patient´s prognosis
Analysis of the mutational landscape of oropharyngeal cancer cases. — 4 years Correlation of tumor mutational burden (TMB) with cancer patient´s prognosis.
Analysis of the mutational landscape of cervical cancer cases. — 4 years Correlation of tumor mutational burden (TMB) with cancer patient´s prognosis.
Trial sites (1)
Facility
City
Region
Status
University Hospital Olomouc
Olomouc
Czechia
Recruiting
More The Institute of Molecular and Translational Medicine, Czech Republic trials in Czechia
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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