CHU Brugmann
Brussels, 1020, Belgium
NCT Number: NCT03920800
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.
Looking for future studies?
Notify Me18 year–35 year
All sexes
Observational
Brussels, 1020, Belgium
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Data extraction from medical files
Immunohistochemistry with Ki67 and p16 antibodies on residual samples, if this had not been foreseen in the standard of care management of the patient.
Time frame: 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.
Time frame: Every six months over a period of 24 months
Cytologic results of the cervico-uterine smear. Diagnose established by the anatomo-pathologist.
Time frame: Every six months over a period of 24 months
Histologic results of the cervical biopsies.Diagnose established by the anatomo-pathologist.
Time frame: Every six months over a period of 24 months
Defined as the number of quadrants reached by the lesion.
Time frame: Every six months over a period of 24 months
Is the endocervix affected by the HSIL lesion (yes or no) ?
Time frame: Every six months over a period of 24 months
Percentage of Ki67 antibody reactivity on the cervix biopsies
Time frame: Every six months over a period of 24 months
Percentage of p16 antibody reactivity on the cervix biopsies
Time frame: Every six months over a period of 24 months
Total number of pregnancies
Time frame: Every six months over a period of 24 months
Total number of children born
Time frame: 1 day
Age at first patient visit
Time frame: Every six months over a period of 24 months
HIV positive or negative
Time frame: Every six months over a period of 24 months
Smoking or non smoking
Time frame: Up to 24 months
Time between the patient's appointment and the receipt of the convocation for colposcopy
Time frame: Every six months over a period of 24 months
Positive or negative for HPV virus
Time frame: Every six months over a period of 24 months
Defined as satisfactory or unsatisfactory (junction area completely seen or not seen).
Catherine Vanpachterbeke
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06651957
Acquired Immunodeficiency Syndrome, Blood-Borne Infections
San Francisco, California, United States
View Trial DetailsNCT06325592
High-Grade Squamous Intraepithelial Lesions, Morphological and Microscopic Findings
Chengdu, Sichuan, China
View Trial DetailsNCT04177641
High-Grade Squamous Intraepithelial Lesions, Low Grade Squamous Intraepithelial Lesion
Muğla, Turkey (Türkiye)
View Trial DetailsNCT03239223
CIN, Cervical Cancer
Los Angeles, California, United States
View Trial Details