HPV Immunological Markers of Cervical Persistent Infection and Oncogenesis

NCT06339684 | Active Not Recruiting

• 1 other identifier: 2021 0075257
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

HPV-Related Cervical Carcinoma

Outcome Measures

Primary Outcomes (1)

• Analysis plan for primary end-point

  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.

  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)

Secondary Outcomes (1)

• Analysis plan for secondary end-points

  Follow-up program implies colposcopy every six months for 2 years

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study population will be identified among women with abnormal PAP test undergoing colposcopy at Fondazione IRCCS Policlinico San Matteo.

You may qualify if:

• Age\>18 years.
• Abnormal PAP test
• HPV DNA positive

You may not qualify if:

• Inability to comply with the requirements of the protocol.

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

Study Sites (1)

Fondazione IRCCS Policlinico San Matteo

Pavia, Italy

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood and cervical samples (vaginal washing, cervical biopsy and pap-smear)

Study Officials

• Barbara Gardella, MD

  Fondazione IRCCS Policlinico San Matteo, Pavia, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: April 1, 2024
• Study Start: March 8, 2023
• Primary Completion: March 8, 2026
• Study Completion: March 8, 2026
• Last Updated: November 5, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)