High-Grade Squamous Intraepithelial Lesions
Conditions
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.
Interventions
Data extraction from medical files
BIOLOGICALImmunohistochemistry
Immunohistochemistry with Ki67 and p16 antibodies on residual samples, if this had not been foreseen in the standard of care management of the patient.
Sponsors
Catherine Vanpachterbeke
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| Extent of dysplastic lesions | Every six months over a period of 24 months | Defined as the number of quadrants reached by the lesion. |
| Endocervix damage | Every six months over a period of 24 months | Is the endocervix affected by the HSIL lesion (yes or no) ? |
| 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
| Measure | Time frame | Description |
|---|---|---|
| Gestity | Every six months over a period of 24 months | Total number of pregnancies |
| 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). |
| Parity | Every six months over a period of 24 months | Total number of children born |
| Age at first patient visit | 1 day | Age at first patient visit |
| 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 |
| 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 |
| HPV status | Every six months over a period of 24 months | Positive or negative for HPV virus |
Countries
Belgium
Outcome results
None listed