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Completed

NCT Number: NCT03920800

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

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.

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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Brugmann

Brussels, 1020, Belgium

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Data extraction from medical files

Other

Data extraction from medical files

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.

Primary outcomes

  1. Patient observance

    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.

  2. Cytologic results of the cervico-uterine smear.

    Time frame: Every six months over a period of 24 months

    Cytologic results of the cervico-uterine smear. Diagnose established by the anatomo-pathologist.

  3. Histologic results of the cervical biopsies

    Time frame: Every six months over a period of 24 months

    Histologic results of the cervical biopsies.Diagnose established by the anatomo-pathologist.

  4. Extent of dysplastic lesions

    Time frame: Every six months over a period of 24 months

    Defined as the number of quadrants reached by the lesion.

  5. Endocervix damage

    Time frame: Every six months over a period of 24 months

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

  6. Immuno-histologic results Ki67

    Time frame: Every six months over a period of 24 months

    Percentage of Ki67 antibody reactivity on the cervix biopsies

  7. Immuno-histologic results p16

    Time frame: Every six months over a period of 24 months

    Percentage of p16 antibody reactivity on the cervix biopsies

Secondary outcomes

  1. Gestity

    Time frame: Every six months over a period of 24 months

    Total number of pregnancies

  2. Parity

    Time frame: Every six months over a period of 24 months

    Total number of children born

  3. Age at first patient visit

    Time frame: 1 day

    Age at first patient visit

  4. HIV status

    Time frame: Every six months over a period of 24 months

    HIV positive or negative

  5. Smoking status

    Time frame: Every six months over a period of 24 months

    Smoking or non smoking

  6. Response time to the convocation for colposcopy

    Time frame: Up to 24 months

    Time between the patient's appointment and the receipt of the convocation for colposcopy

  7. HPV status

    Time frame: Every six months over a period of 24 months

    Positive or negative for HPV virus

  8. Quality of colposcopic examinations

    Time frame: Every six months over a period of 24 months

    Defined as satisfactory or unsatisfactory (junction area completely seen or not seen).

Sponsors and collaborators

Lead sponsor

Catherine Vanpachterbeke

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 19, 2019
Registry last updated
Jul 20, 2022

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.

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