Role of Liquid Biopsies in HPV-associated Cancer Treatment Monitoring
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorThe Institute of Molecular and Translational Medicine, Czech Republic
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
Oropharyngeal cancer patients, Cervical cancer patients
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Arm A - Diagnostic test: HPV detection in liquid biopsies
Diagnostic testPatients 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 testPatients will be asked to perform cervicovaginal self-sampling using Evalyn Brush. Blood samples will be taken by trained clinicians.
Treatment groups
480 Participants
are divided into 2 treatment groupsGroup A: Arm A - Oropharyngeal cancer patients1 intervention
Group B: Arm B - Cervical cancer patients1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
4 years2
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.
Time frame
4 years3
Dynamics of circulating tumor (ct) HPV DNA in oropharyngeal cancer patients.
Correlation of plasmatic ct HPV DNA level with cancer patient´s prognosis.
Time frame
4 years4
Dynamics of circulating tumor (ct) HPV DNA in cervical cancer patients
Correlation of plasmatic ct HPV DNA level with patient´s prognosis
Time frame
4 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
The Institute of Molecular and Translational Medicine, Czech Republic
Lead sponsor
National Institute for Cancer Research, Czech Republic
Collaborator
University Hospital Olomouc
Collaborator
Source ClinicalTrials.gov