Impact of HPV Vaccination on Cervical High Grade Lesions in France

NCT04167501 | Completed

• 1 other identifier: P/2019/454
• Study Type: observational
• Target: 606
• Locations: 1 country
• Sites: 1

Brief Summary

The objective is to estimate the prevalence of the different genotypes of human papillomaviruses (HPV) in histologically proven high-grade lesions of the cervix in patients born between 1972 and 1993. It is plan to determine if the prevalence of HPV16 and HPV18 is lower in the population born between 1983 and 1993 and potentially exposed to HPV vaccination compared to those born between 1972 and 1982 who were not exposed to vaccination. Thus the investigators should be able to determine whether the introduction of HPV vaccination in France in 2007 has had an impact on the development of high-grade lesions associated with HPV16 and HPV18.

Conditions

Human Papillomavirus Infection

Keywords

cervical precancerous lesion; HPV; vaccination; Impact study; France

Outcome Measures

Primary Outcomes (1)

• HPV16 and HPV18 prevalence

  Prevalence of HPV16 and HPV18 genotypes in high grade cervical lesions of the cervix in women born between 1972 and 1993

  18 months

Secondary Outcomes (1)

• Other HPV prevalence

  18 months

Study Arms (2)

Non exposed

Women born between 1972 and 1982 who were not exposed to HPV vaccination

Other: biological sample analysis

exposed

Women born between 1983 and 1993 who were potentially exposed to HPV vaccination

Other: biological sample analysis

Interventions

biological sample analysis OTHER

HPV Prevalence analysis

Non exposed; exposed

Eligibility Criteria

• Age: 27 Years - 46 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Women born between 1972 and 1993

You may qualify if:

• High grade lesions of the cervix
• Histologic diagnosis of cervical intraepithelial neoplasia grade 2 or 3, carinoma in situ
• Biopsy or surgical specimen
• Formalin-fixed ans paraffin embedded specimen

You may not qualify if:

• \- samples fixed in Boin's solution

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (1)

CHU Besançon

Besançon, France

Location

Related Publications (1)

• Lenoir P, Guillet J, Desmarets M, Baraquin A, Ramanah R, Rousse J, Mougin C, Lepiller Q, Pretet JL; HPV Impact Study Group. Human papillomavirus genotype distribution among high-grade cervical lesions in French women born between 1972 and 1993. J Gynecol Obstet Hum Reprod. 2025 May;54(5):102945. doi: 10.1016/j.jogoh.2025.102945. Epub 2025 Mar 21.

  PMID: 40122237 DERIVED

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jean-Luc PRETET, Pr

  Centre Hospitalier Universitaire de Besançon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2019
• First Posted: November 19, 2019
• Study Start: February 1, 2020
• Primary Completion: May 1, 2021
• Study Completion: June 1, 2021
• Last Updated: August 23, 2021

Record last verified: 2020-07

Locations

FR (1)