Preventing Invasive Cervical Cancer: The Importance of Expectant Management in Young Women With High-grade Pre-cancerous Lesions

NCT ID: NCT03920800

Last Updated: 2022-07-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2019-11-20

Brief Summary

Lesions classified as "High Grade Squamous Intra-epithelial Lesions" (HSIL) are pre-cervical lesions of the cervix, induced by infection with the Human Papilloma Virus (HPV). The detection and proper management of these lesions greatly reduces the incidence of invasive cervical cancer.

Pap smear remains the most effective tool for early detection of low and high-grade cervical lesions. In Belgium, screening for cervical cancer is recommended every 3 years for women between 25 and 65 years old.

HPV is a virus who possesses certain oncogenic genes who have the ability to inactivate tumor suppressor genes in the host cell. This promotes a tumorigenesis process within the tissues affected by the virus. The majority of human papillomavirus infections are transient and spontaneously cleared by host defense mechanisms, especially in the first two years after exposure. However, 10-20% of infections persist latently and may eventually lead to progression to invasive cervical cancer.

Even high-grade lesions kan naturally be cleared, even more so if the patient is young and immuno-competent. Therefore, the management of HSIL lesions in young women has been modified and consists of adopting mainly a conservative attitude, with controls every 6 months for 2 years. This management makes it possible to avoid unnecessary conizations of the cervix which, in young nulliparous patients, are not devoid of heavy obstetric consequences during subsequent pregnancies (premature birth, perinatal mortality). Cervical conization will only be considered for lesions that progress during follow-up or that persist beyond 2 years. However, this type of follow-up requires that patients be compliant.

Our study has two main objectives:

• to determine the compliance of CHU Brugmann Hospital patients who have been proposed a conservative strategy for the management of HSIL lesions.
• to identify the predictive factors for the persistence and / or progression of high-grade pre-cancerous dysplastic lesions.

Conditions

High-Grade Squamous Intraepithelial Lesions

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Conservative management - progression

Young women with high grade pre-cancerous lesions, followed within the CHU Brugmann Hospital according to a conservative attitude, with progressive lesions or lesions remaining present after 2 years of follow-up.

Data extraction from medical files

Intervention Type: OTHER

Data extraction from medical files

Immunohistochemistry

Intervention Type: BIOLOGICAL

Immunohistochemistry with Ki67 and p16 antibodies on residual samples, if this had not been foreseen in the standard of care management of the patient.

Conisation

Young women with high grade pre-cancerous lesions, followed within the CHU Brugmann Hospital by means of conisations.

Data extraction from medical files

Intervention Type: OTHER

Data extraction from medical files

Immunohistochemistry

Intervention Type: BIOLOGICAL

Immunohistochemistry with Ki67 and p16 antibodies on residual samples, if this had not been foreseen in the standard of care management of the patient.

Conservative management - spontaneous regression

Young women with high grade pre-cancerous lesions, followed within the CHU Brugmann Hospital according to a conservative attitude, who showed a spontaneous regression of the lesions during the 2 years follow-up.

Data extraction from medical files

Intervention Type: OTHER

Data extraction from medical files

Immunohistochemistry

Intervention Type: BIOLOGICAL

Immunohistochemistry with Ki67 and p16 antibodies on residual samples, if this had not been foreseen in the standard of care management of the patient.

Interventions

Data extraction from medical files

Data extraction from medical files

Intervention Type: OTHER

Immunohistochemistry

Immunohistochemistry with Ki67 and p16 antibodies on residual samples, if this had not been foreseen in the standard of care management of the patient.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Patients followed within the CHU Brugmann Hospital (no private practices).
• HSIL lesions confirmed by anatomopathologic analysis on cervical biopsies or cone specimen without evidence of invasive lesions

Exclusion Criteria

• Invasive lesions

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Catherine Vanpachterbeke

OTHER

Sponsor Role: lead

Responsible Party

Catherine Vanpachterbeke

Head of clinic

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Georges Salem Wehbe, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Brugmann

Locations

CHU Brugmann

Brussels, , Belgium

Countries

Belgium

Other Identifiers

CHUB-Salem Wehbe

Identifier Type: -

Identifier Source: org_study_id