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

NCT03920800 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2022-07-20

No results posted yet for this study

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.

Conditions

  • High-Grade Squamous Intraepithelial Lesions

Interventions

OTHER

Data extraction from medical files

Data extraction from medical files

BIOLOGICAL

Immunohistochemistry

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 & Collaborators

  • Catherine Vanpachterbeke

    lead OTHER

Principal Investigators

  • Georges Salem Wehbe, MD · CHU Brugmann

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-01
Primary Completion
2019-11-20
Completion
2019-11-20

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03920800 on ClinicalTrials.gov