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

NCT03920800 | Completed

• 1 other identifier: CHUB-Salem Wehbe
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

High-Grade Squamous Intraepithelial Lesions

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• Extent of dysplastic lesions

  Defined as the number of quadrants reached by the lesion.

  Every six months over a period of 24 months

• Endocervix damage

  Is the endocervix affected by the HSIL lesion (yes or no) ?

  Every six months over a period of 24 months

• Immuno-histologic results Ki67

  Percentage of Ki67 antibody reactivity on the cervix biopsies

  Every six months over a period of 24 months

• Immuno-histologic results p16

  Percentage of p16 antibody reactivity on the cervix biopsies

  Every six months over a period of 24 months

Secondary Outcomes (8)

• Gestity

  Every six months over a period of 24 months

• Parity

  Every six months over a period of 24 months

• Age at first patient visit

  1 day

• HIV status

  Every six months over a period of 24 months

• Smoking status

  Every six months over a period of 24 months

Study Arms (3)

Conservative management - progression

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.

Other: Data extraction from medical files; Biological: Immunohistochemistry

Conisation

Young women with high grade pre-cancerous lesions, followed within the CHU Brugmann Hospital by means of conisations.

Other: Data extraction from medical files; Biological: Immunohistochemistry

Conservative management - spontaneous regression

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.

Other: Data extraction from medical files; Biological: Immunohistochemistry

Interventions

Data extraction from medical files OTHER

Data extraction from medical files

Conisation; Conservative management - progression; Conservative management - spontaneous regression

Immunohistochemistry BIOLOGICAL

Immunohistochemistry with Ki67 and p16 antibodies on residual samples, if this had not been foreseen in the standard of care management of the patient.

Conisation; Conservative management - progression; Conservative management - spontaneous regression

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Young women followed within the CHU Brugmann Hospital for HSIL lesions.

You may qualify if:

• 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

You may not qualify if:

• Invasive lesions

Sponsors & Collaborators

• Catherine Vanpachterbeke: lead

Study Sites (1)

CHU Brugmann

Brussels, 1020, Belgium

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

* Pap smear * Cervical biopsies

MeSH Terms

Conditions

Squamous Intraepithelial Lesions

Interventions

Immunohistochemistry

Condition Hierarchy (Ancestors)

Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Investigative Techniques; Immunologic Techniques

Study Officials

• Georges Salem Wehbe, MD

  CHU Brugmann

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of clinic

Study Record Dates

• First Submitted: April 16, 2019
• First Posted: April 19, 2019
• Study Start: March 1, 2019
• Primary Completion: November 20, 2019
• Study Completion: November 20, 2019
• Last Updated: July 20, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)