Clinical trial · Observational
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
NCT05774561CI-TRIAL-00103096recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Cervical Dysplasia | Cervical Intraepithelial Neoplasia | ALIAS | 0.90 |
| Human Papillomavirus Infection | — | UNRESOLVED | — |
| Oropharyngeal Cancer | Malignant Oropharyngeal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Arm A - Diagnostic test: HPV detection in liquid biopsies | Diagnostic Test | — | UNRESOLVED |
| Arm B - Diagnostic test: HPV detection in liquid biopsies | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Arm A - Oropharyngeal cancer patients
- description
- 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.
- interventionNames
- Diagnostic Test: Arm A - Diagnostic test: HPV detection in liquid biopsies
- label
- Arm B - Cervical cancer patients
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.