Investigating multiple HPV infections and their role in cervical changes
Prospective Clinical Study on the Role of Multiple Human Papillomavirus Infections in Lower Genital Tract Dysplasias and Its Interactions with HPV Vaccination
This study looks at how common multiple high-risk HPV infections are in people with abnormal cervical tests to see how they might affect cervical health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 152 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia Academic / other |
| Locations | 1 site (Pavia, Pavia) |
| Trial ID | NCT06862102 on ClinicalTrials.gov |
What this trial studies
This observational study examines the prevalence and clustering of multiple high-risk Human Papillomavirus (HR-HPV) infections in patients with abnormal cervical cytological or histological findings. It aims to understand the epidemiological and methodological factors that contribute to the variability in the detection of these infections. The study will include patients with dysplastic cervical lesions and those diagnosed with Cervical Intraepithelial Neoplasia (CIN) or early-stage invasive cervical cancer. The findings may help clarify the associations between different HPV genotypes and their implications for cervical health.
Who should consider this trial
Good fit: Ideal candidates include individuals with abnormal cervical cytology suggestive of dysplastic lesions or those diagnosed with CIN.
Not a fit: Patients who are pregnant, under 18 years old, or have received treatment for HPV-related lesions in the past five years may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of HPV infections and improve screening and treatment strategies for cervical cancer.
How similar studies have performed: While some studies have explored HPV clustering, this specific investigation into multiple infections and their associations is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pap smear cytology suggestive of dysplastic cervical lesion worthy of colposcopic evaluation and HPV test * HPV-related vaginal and/or vulvar lesion * patients with histological diagnosis after biopsy of Cervical Intraepithelial Neoplasia (CIN) or invasive cervical cancer of stage lower than FIGO staging 1B. Exclusion Criteria: * pregnancy * age less than 18 years * previous treatment for HPV-related vaginal, vulvar or cervical lesion in the previous 5 years
Where this trial is running
Pavia, Pavia
- Fondazione IRCCS Policlinico San Matteo, SC Ostetricia e Ginecologia 1 — Pavia, Pavia, Italy (Recruiting)
Study contacts
- Study coordinator: Barbara Gardella, Principal investigator
- Email: b.gardella@smatteo.pv.it
- Phone: +390382503720
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.