Clinical trial · Observational
HPV Immunological Markers of Cervical Persistent Infection and Oncogenesis
- 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 aim of this observational study is to build an immunological assay to quantify an immunoscore system for clinical practice, which could identify HPV lesions with a risk of persistent cervical infection, which represents the main predictive factor of neoplastic evolution. A pattern of host immunological factors and HPV-related parameters, in order to identify an algorithm of risk stratification and tailoring treatment will be identified. Finally, in patients with HPV infection, a virus specific immunity after vaccination will be quantified, in order to highlight those patients who have the most significant risk of infection persistence.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HPV-Related Cervical Carcinoma | Human Papillomavirus-Related Cervical Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Analysis plan for primary end-point
- timeFrame
- Time 0 (enrollment), Time 1 (6 months after colposcopy), Time 2 (12 months after colposcopy), Time 3 (18 months after colposcopy) and T4 (24 months after colposcopy)
- description
- Univariable and multivariable interval-censoring Cox models will be applied to estimate the hazard ratios (HRs) of progression (advanced high grade lesions) at 2 years according to HPV-specific T cell response and HPV viral load measured at time of diagnosis. The best model will be selected based on Accuracy, Sensitivity, Specificity and Area Under Curve (AUC). LogRRs derived from the best model will be rounded to the closest integer and used to create a predictive score. Clustered sandwich estimator will be used to estimate standard errors, in order to account for the intra-patient correlation.
Secondary outcomes (1)
- measure
- Analysis plan for secondary end-points
- timeFrame
- Follow-up program implies colposcopy every six months for 2 years
- description
- The effect of HPV Vaccine on progression will be analyzed by univariable and multivariable interval-censoring Cox models at six months after vaccination. Vaccine will be analyzed as a time dependent covariate. All analyses will be performed using the Stata software (release 16,StataCorp, College Station, TX, USA).
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age\>18 years. * Abnormal PAP test * HPV DNA positive Exclusion Criteria: * Inability to comply with the requirements of the protocol.
References
Publications (0)
Data not yet available