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

  • Clinicaltrials.gov identifier

    NCT03920800

  • Recruitment Status

    Recruiting

  • First Posted

    April 19, 2019

  • Last update posted

    April 19, 2019

Study Description

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.

  • Condition or Disease:High-Grade Squamous Intraepithelial Lesions
  • Intervention/Treatment: Other: Data extraction from medical files
    Biological: Immunohistochemistry
  • Phase: N/A

Detailed Description

N/A

Study Design

  • Study Type: Observational
  • Estimated Enrollment: 100 participants
  • Observational Model: Cohort
  • Time Perspective: Retrospective
  • Official Title: Preventing Invasive Cervical Cancer: The Importance of Expectant Management in Young Women With High-grade Pre-cancerous Lesions
  • Actual Study Start Date: March 2019
  • Estimated Primary Completion Date: December 2020
  • Estimated Study Completion Date: December 2020

Groups and Cohorts

Groups/Cohorts Intervention/treatment
: 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
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.
: 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
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.
: 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
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.

Outcome Measures

  • Primary Outcome Measures: 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 Outcome Measures: 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).
  • Biospecimen Retention: Samples Without DNA

    - Pap smear - Cervical biopsies

Eligibility Criteria

  • Ages Eligible for Study: 18 to 35 Years (Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers:
  • Sampling Method: Non-Probability Sample
  • Study Population: Young women followed within the CHU Brugmann Hospital for HSIL lesions.

Criteria

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

Contacts and Locations

Contacts

Contact: Georges Salem Wehbe, MD 3224772010 Georges.SALEMWEHBE@chu-brugmann.be

Locations

Belgium
CHU Brugmann
Brussels

Sponsors and Collaborators

Catherine Vanpachterbeke

Investigators

Principal Investigator: Georges Salem Wehbe, MD CHU Brugmann

More Information

  • Responsible Party: Catherine Vanpachterbeke
  • ClinicalTrials.gov Identifier: NCT03920800 History of Changes
  • Other Study ID Numbers: CHUB-Salem Wehbe
  • First Posted: April 19, 2019 Key Record Dates
  • Last Update Posted: April 19, 2019
  • Last Verified: April 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Uterine Cervical Neoplasms Squamous Intraepithelial Lesions of the Cervix