Preventing Invasive Cervical Cancer: The Importance of Expectant Management in Young Women With High-grade Pre-cancerous Lesions
- Conditions
- High-Grade Squamous Intraepithelial Lesions
- Interventions
- Other: Data extraction from medical filesBiological: Immunohistochemistry
- Registration Number
- NCT03920800
- Lead Sponsor
- Catherine Vanpachterbeke
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- 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
- Invasive lesions
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Conservative management - progression Immunohistochemistry 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. Conisation Immunohistochemistry Young women with high grade pre-cancerous lesions, followed within the CHU Brugmann Hospital by means of conisations. Conservative management - spontaneous regression Data extraction from medical files 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. Conservative management - progression Data extraction from medical files 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. Conisation Data extraction from medical files Young women with high grade pre-cancerous lesions, followed within the CHU Brugmann Hospital by means of conisations. Conservative management - spontaneous regression Immunohistochemistry 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.
- Primary Outcome Measures
Name Time Method Cytologic results of the cervico-uterine smear. Every six months over a period of 24 months Cytologic results of the cervico-uterine smear. Diagnose established by the anatomo-pathologist.
Patient observance Every six months over a period of 24 months Numeric value: 1 (optimal), 2 (acceptable), 3 (absent).
Groups having benefited from a conservative attitude: Optimal compliance: 4 consultations in 24 months and / or indication of conization. Acceptable compliance: 2 to 3 consultations in 24 months. Observance absent: 0 to 1 consultation in 24 months. Groups having benefited from conization:
Optimal compliance: 2 consultations after conisation. Acceptable compliance: 1 after consultation. Observance absent: 0 consultation after conisation.Endocervix damage Every six months over a period of 24 months Is the endocervix affected by the HSIL lesion (yes or no) ?
Extent of dysplastic lesions Every six months over a period of 24 months Defined as the number of quadrants reached by the lesion.
Histologic results of the cervical biopsies Every six months over a period of 24 months Histologic results of the cervical biopsies.Diagnose established by the anatomo-pathologist.
Immuno-histologic results Ki67 Every six months over a period of 24 months Percentage of Ki67 antibody reactivity on the cervix biopsies
Immuno-histologic results p16 Every six months over a period of 24 months Percentage of p16 antibody reactivity on the cervix biopsies
- Secondary Outcome Measures
Name Time Method Gestity Every six months over a period of 24 months Total number of pregnancies
Parity Every six months over a period of 24 months Total number of children born
Quality of colposcopic examinations Every six months over a period of 24 months Defined as satisfactory or unsatisfactory (junction area completely seen or not seen).
Age at first patient visit 1 day Age at first patient visit
Response time to the convocation for colposcopy Up to 24 months Time between the patient's appointment and the receipt of the convocation for colposcopy
HIV status Every six months over a period of 24 months HIV positive or negative
Smoking status Every six months over a period of 24 months Smoking or non smoking
HPV status Every six months over a period of 24 months Positive or negative for HPV virus
Trial Locations
- Locations (1)
CHU Brugmann
🇧🇪Brussels, Belgium