Liquid Biopsies - a Possible Tool for Treatment Monitoring and Early Recurrence Detection in HPV-associated Diseases
Status: Recruiting
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:
• Women diagnosed with CC/HSIL. Men and women diagnosed with OPC. Patients must agree with study enrollment and must sign study informed consent.
Contact Information
Primary
Marian Hajduch, MD., PhD.
marian.hajduch@upol.cz
+420 585 632 083
Backup
Vladimira Koudelakova, MSc, Ph.D.
vladimira.koudelakova@upol.cz
+420 585 632 089
Time Frame
Start Date: 2022-06-01
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 480
Treatments
Active_comparator: 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.
Active_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: The Institute of Molecular and Translational Medicine, Czech Republic
Collaborators: National Institute for Cancer Research, Czech Republic, University Hospital Olomouc