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

High-Grade Squamous Intraepithelial Lesions Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03920800
• Other study ID #: CHUB-Salem Wehbe
• Status: Completed
• Start date: March 1, 2019
• Est. completion date: November 20, 2019

Study information

• Verified date: July 2022
• Source: Brugmann University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 20, 2019
• Est. primary completion date: November 20, 2019
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• High-Grade Squamous Intraepithelial Lesions
• Uterine Cervical Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Belgium	CHU Brugmann	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Catherine Vanpachterbeke

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient observance	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.	Every six months over a period of 24 months
Primary	Cytologic results of the cervico-uterine smear.	Cytologic results of the cervico-uterine smear. Diagnose established by the anatomo-pathologist.	Every six months over a period of 24 months
Primary	Histologic results of the cervical biopsies	Histologic results of the cervical biopsies.Diagnose established by the anatomo-pathologist.	Every six months over a period of 24 months
Primary	Extent of dysplastic lesions	Defined as the number of quadrants reached by the lesion.	Every six months over a period of 24 months
Primary	Endocervix damage	Is the endocervix affected by the HSIL lesion (yes or no) ?	Every six months over a period of 24 months
Primary	Immuno-histologic results Ki67	Percentage of Ki67 antibody reactivity on the cervix biopsies	Every six months over a period of 24 months
Primary	Immuno-histologic results p16	Percentage of p16 antibody reactivity on the cervix biopsies	Every six months over a period of 24 months
Secondary	Gestity	Total number of pregnancies	Every six months over a period of 24 months
Secondary	Parity	Total number of children born	Every six months over a period of 24 months
Secondary	Age at first patient visit	Age at first patient visit	1 day
Secondary	HIV status	HIV positive or negative	Every six months over a period of 24 months
Secondary	Smoking status	Smoking or non smoking	Every six months over a period of 24 months
Secondary	Response time to the convocation for colposcopy	Time between the patient's appointment and the receipt of the convocation for colposcopy	Up to 24 months
Secondary	HPV status	Positive or negative for HPV virus	Every six months over a period of 24 months
Secondary	Quality of colposcopic examinations	Defined as satisfactory or unsatisfactory (junction area completely seen or not seen).	Every six months over a period of 24 months