High-Grade Squamous Intraepithelial LesionsNCT03920800
Preventing Invasive Cervical Cancer: The Importance of Expectant Management in Young Women With High-grade Pre-cancerous Lesions
An observational study of High-Grade Squamous Intraepithelial Lesions, run by Catherine Vanpachterbeke at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- High-Grade Squamous Intraepithelial Lesions
- What is being tested?
- Data extraction from medical files and Immunohistochemistry
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Mar 2019to 20 Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Adult
Study population: Young women followed within the CHU Brugmann Hospital for HSIL lesions.
Who may be able to join
- 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
Who cannot join
- Invasive lesions
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Being tested
- Data extraction from medical files, Immunohistochemistry
- Medical subject headings
- Squamous Intraepithelial Lesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data extraction from medical filesOther
Data extraction from medical files
ImmunohistochemistryBiological
Immunohistochemistry with Ki67 and p16 antibodies on residual samples, if this had not been foreseen in the standard of care management of the patient.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Data extraction from medical files; Biological: Immunohistochemistry |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Every six months over a period of 24 months
Extent of dysplastic lesions
Defined as the number of quadrants reached by the lesion.
Measured: Every six months over a period of 24 months
Endocervix damage
Is the endocervix affected by the HSIL lesion (yes or no) ?
Measured: Every six months over a period of 24 months
Immuno-histologic results Ki67
Percentage of Ki67 antibody reactivity on the cervix biopsies
Measured: Every six months over a period of 24 months
Immuno-histologic results p16
Percentage of p16 antibody reactivity on the cervix biopsies
Measured: Every six months over a period of 24 months
Secondary outcomes (8)
Gestity
Total number of pregnancies
Measured: Every six months over a period of 24 months
Parity
Total number of children born
Measured: Every six months over a period of 24 months
Age at first patient visit
Age at first patient visit
Measured: 1 day
HIV status
HIV positive or negative
Measured: Every six months over a period of 24 months
Smoking status
Smoking or non smoking
Measured: Every six months over a period of 24 months
Response time to the convocation for colposcopy
Time between the patient's appointment and the receipt of the convocation for colposcopy
Measured: Up to 24 months
HPV status
Positive or negative for HPV virus
Measured: Every six months over a period of 24 months
Quality of colposcopic examinations
Defined as satisfactory or unsatisfactory (junction area completely seen or not seen).
Measured: Every six months over a period of 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2019
- Study start1 Mar 2019
- Primary completion20 Nov 2019
- Study completion20 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-Grade Squamous Intraepithelial LesionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catherine Vanpachterbeke
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Catherine Vanpachterbeke, Brugmann University Hospital
- Investigators
- Georges Salem Wehbe, MD, Principal investigator, CHU Brugmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03920800
- Sponsor's protocol ID
- CHUB-Salem Wehbe
- Status last verified
- Jul 2022
- First submitted
- 16 Apr 2019
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Invasive Cervical Cancer: The Importance of Expectant Management in Young Women With High-grade Pre-cancerous Lesions
- ClinicalTrials.gov ID
- NCT03920800
- Acronym / sponsor ID
- CHUB-Salem Wehbe
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Catherine VanpachterbekeUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 20 Nov 2019 (actual)
- Study completion
- 20 Nov 2019 (actual)
- First posted
- 19 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conservative management - progression | – | Other: Data extraction from medical files, Biological: ImmunohistochemistryYoung 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. |
| Conisation | – | Other: Data extraction from medical files, Biological: ImmunohistochemistryYoung women with high grade pre-cancerous lesions, followed within the CHU Brugmann Hospital by means of conisations. |
| Conservative management - spontaneous regression | – | Other: Data extraction from medical files, Biological: ImmunohistochemistryYoung 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Age groups
- Adult
- Study population
- Young women followed within the CHU Brugmann Hospital for HSIL lesions.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Invasive lesions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data extraction from medical filesData extraction from medical files | Other | Conisation, Conservative management - progression, Conservative management - spontaneous regression |
| ImmunohistochemistryImmunohistochemistry with Ki67 and p16 antibodies on residual samples, if this had not been foreseen in the standard of care management of the patient. | Biological | Conisation, Conservative management - progression, Conservative management - spontaneous regression |
Primary outcome
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.
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.
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.
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.
Endocervix damage
Time frame: Every six months over a period of 24 months
Is the endocervix affected by the HSIL lesion (yes or no) ?
Immuno-histologic results Ki67
Time frame: Every six months over a period of 24 months
Percentage of Ki67 antibody reactivity on the cervix biopsies
Immuno-histologic results p16
Time frame: Every six months over a period of 24 months
Percentage of p16 antibody reactivity on the cervix biopsies
8 secondary outcomes
Gestity
Time frame: Every six months over a period of 24 months
Parity
Time frame: Every six months over a period of 24 months
Age at first patient visit
Time frame: 1 day
HIV status
Time frame: Every six months over a period of 24 months
Smoking status
Time frame: Every six months over a period of 24 months
Response time to the convocation for colposcopy
Time frame: Up to 24 months
HPV status
Time frame: Every six months over a period of 24 months
Quality of colposcopic examinations
Time frame: Every six months over a period of 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Georges Salem Wehbe, MD principal investigator
CHU Brugmann
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of High-Grade Squamous Intraepithelial Lesions, run by Catherine Vanpachterbeke at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient observance (time frame: Every six months over a period of 24 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2022.