Clinical trial · Interventional
Blood Biomarkers Based Screening for HPV-driven OPC
SCREEN-HPV: Blood Biomarkers Based Screening for HPV-driven OPC
- 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)
The objective of our study is to demonstrate that it is possible to detect and treat human papilloma virus (HPV)-related oropharyngeal cancers (OPC) early using simple blood tests. The success of this strategy will be evaluated by the number of participants positive for both HPV16-E6 serology and HPV circulating tumor DNA (ctDNA) whose early management has allowed the detection of a cancerous lesion and/or whose HPV ctDNA results have normalized after surgical intervention. If this study is conclusive, it could pave the way for the implementation of a national screening strategy for HPV-related OPC.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anal Cancer | Malignant Anal Neoplasm | CURATED_EXACT | 0.92 |
| Head and Neck Squamous Cell Carcinoma | Head and Neck Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Human Papilloma Virus | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HPV16-E6 serology and HPV ctDNA | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Control group
- description
- For the first 500 participants enrolled, one additional blood sample will be drawn in DNA-free tubes for HPV ctDNA analysis. As we expect to have around 1% seropositive cases, most of these 500 samples will be seronegative and will constitute our control group. These controls will be tested for HPV ctDNA to confirm that seronegative participants are also HPV ctDNA-negative
- interventionNames
- Diagnostic Test: HPV16-E6 serology and HPV ctDNA
- type
- EXPERIMENTAL
- label
- Experimental Group
- description
- Individuals who are seropositive for HPV16-E6 will be contacted to propose the participation in the second part of the study and benefit from specific assessment and monitoring for 5 years (HPV ctDNA testing, regular clinical examinations of the head \& neck and anal-genital regions, imaging if needed).
- interventionNames
- Diagnostic Test: HPV16-E6 serology and HPV ctDNA
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * Aged ≥50 years from the general population * Man * No previous history of HPV-driven cancer or head neck cancer * Willingness to complete follow up visits Exclusion Criteria: * Aged \< 50 years * Woman * History of HPV-driven cancer or head and neck cancer * Psychiatric conditions * Inability to complete follow up visits * Severe medical condition (life expectancy \<5 years) * Previous prophylactic HPV vaccination
References
Publications (0)
Data not yet available