Clinical trial NCT03920800: Preventing Invasive Cervical Cancer: The Importance of Expectant Management in Young Women With High-grade Pre-cancerous Lesions
Official title: Preventing Invasive Cervical Cancer: The Importance of Expectant Management in Young Women With High-grade Pre-cancerous Lesions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: High-Grade Squamous Intraepithelial Lesions
Lead sponsor: Brugmann University Hospital
Sponsor class: OTHER
First posted: 2019-04-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Young women followed within the CHU Brugmann Hospital for HSIL lesions.

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.


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

Primary outcomes:
measure: Patient observance
timeFrame: Every six months over a period of 24 months
measure: Cytologic results of the cervico-uterine smear.
timeFrame: Every six months over a period of 24 months
measure: Histologic results of the cervical biopsies
timeFrame: Every six months over a period of 24 months
measure: Extent of dysplastic lesions
timeFrame: Every six months over a period of 24 months
measure: Endocervix damage
timeFrame: Every six months over a period of 24 months
measure: Immuno-histologic results Ki67
timeFrame: Every six months over a period of 24 months
measure: Immuno-histologic results p16
timeFrame: Every six months over a period of 24 months
Secondary outcomes:
measure: Gestity
timeFrame: Every six months over a period of 24 months
measure: Parity
timeFrame: Every six months over a period of 24 months
measure: Age at first patient visit
timeFrame: 1 day
measure: HIV status
timeFrame: Every six months over a period of 24 months
measure: Smoking status
timeFrame: Every six months over a period of 24 months
measure: Response time to the convocation for colposcopy
timeFrame: Up to 24 months
measure: HPV status
timeFrame: Every six months over a period of 24 months
measure: Quality of colposcopic examinations
timeFrame: Every six months over a period of 24 months
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU Brugmann
Study officials:
affiliation: CHU Brugmann
name: Georges Salem Wehbe, MD
role: PRINCIPAL_INVESTIGATOR
References: