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

Catherine Vanpachterbeke

Status: Completed

Conditions: High-Grade Squamous Intraepithelial Lesions

Treatments: Other: Data extraction from medical files; Biological: Immunohistochemistry

Study type: Observational

Funder types: Other

Identifiers

NCT03920800

CHUB-Salem Wehbe

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 3 patient groups

Conservative management - progression

Description:

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.

Treatment:

Biological: Immunohistochemistry

Other: Data extraction from medical files

Conisation

Description:

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

Treatment:

Biological: Immunohistochemistry

Other: Data extraction from medical files

Conservative management - spontaneous regression

Description:

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.

Treatment:

Biological: Immunohistochemistry

Other: Data extraction from medical files