Skin CancerNCT04886908
Comparative Retrospective Analysis of Skin Tumors of the Eyelids and Face in 2 Brussels University Hospitals Over 5 Years in Dermatology or Ophthalmology
An observational study of Skin Cancer, run by Brugmann University Hospital at 1 site in Belgium.
Trial summary
Skin cancers are the most common of all cancers. Their incidence has increased sharply over the decades.This increase in incidence partly reflects an aging population and behavioral patterns such as repeated exposure to the sun. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Cancer
- What is being tested?
- Data extraction from medical files
- How many people
- 373 participants
- Where
- 1 siteBelgium
- Study dates
- 9 Feb 2021to 28 Jul 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Identification of all patients who have undergone surgical excision of benign or malignant facial and/or eyelid tumors over the past 5 years in the Dermatology and/or Ophthalmology Departments of the CHU Saint-Pierre and CHU Brugmann hospitals.
Who may be able to join
- Final diagnosis confirmed by pathological analysis, epidemiological and clinical information available from patients.
Who cannot join
- Patients who have expressed a refusal to access their medical file or incomplete data will not be taken into account.
Trial locations and contacts
1 site in 1 country.
About this study
Skin cancers are the most common of all cancers. Their incidence has increased sharply over the decades.This increase in incidence partly reflects an aging population and behavioral patterns such as repeated exposure to the sun. Indeed, exposure to UV rays is the predominant factor involved in the pathogenesis of these tumors, hence the fact that they mainly develop in photo-exposed regions such as the cephalic extremity.
The objective of this study is to provide an epidemiological analysis of tumors in the populations of both CHU Brugmann and St Pierre hospitals.
- Conditions
- Skin Cancer
- Being tested
- Data extraction from medical files
- Medical subject headings
- Skin Neoplasms
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Age
Age of the patient at the time of diagnose
Measured: 5 minutes
Sex
Sex of the patient
Measured: 5 minutes
Name of the department in which the patient is followed
Ophthalmology-CHU Brugmann hospital or Dermatology-CHU Brugmann hospital or Ophthalmology- CHU St Pierre Hospital or Dermatology-CHU St Pierre Hospital
Measured: 5 minutes
Tumor anatomical location
Eyelids are distributed in their different regions: internal cantus and external cantus, upper eyelid and lower eyelid. Same for the face: ears, zygomatic, forehead, temples, cheeks, nose, upper lip, lower lip, chin, nasolabial fold, preauricular area, retroauricular area, brow bone.
Measured: 5 minutes
Tumor size
Tumor size in millimeters
Measured: 5 minutes
Laterality
Laterality: left, right, median
Measured: 5 minutes
Multiple or single tumor
Multiple or single tumor
Measured: 5 minutes
Primitive tumor or recidive
Primitive tumor or recidive
Measured: 5 minutes
Risk factor: phototype
Phototype 1 to 6 on the Fitzpatrick scale. The Fitzpatrick scale is a numerical classification schema for human skin color. Type 1 is pale skin that always burns, never tans and type 6 is deeply pigmented dark brown to darkest brown skin that never burns.
Measured: 5 minutes
Risk factor: immunosuppression (yes/no)
Pathogenic or iatrogenic, history of malignant skin tumors other than melanoma, personal or family history of melanoma
Measured: 5 minutes
Risk factor: keratosis
Actinic keratosis of the face
Measured: 5 minutes
Risk factor: solar exposition (yes/no)
Lived in a sunny European country> 1 year, lived in a sunny country outside Europe> 1 year, sunbed use> 1 session, history of solar erythema during childhood.
Measured: 5 minutes
Diagnosis
Time between the appearance of the tumor and the first consultation
Measured: 5 minutes
Locoregional extension report (yes/no)
Locoregional extension report (yes/no)
Measured: 5 minutes
Histological diagnosis of the tumor
Histological diagnosis of the tumor
Measured: 5 minutes
Healthy or invaded margins
Healthy or invaded margins
Measured: 5 minutes
Superficial or infiltrating tumor
Superficial or infiltrating tumor
Measured: 5 minutes
Diagnostic method
Diagnostic method: curettage, punch, biopsy, flattening
Measured: 5 minutes
Surgical management method
Biopsy resection, plasty, graft, second-line healing, enucleation, additional treatment: radiotherapy, immunotherapy, liquid nitrogen
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2021
- Study start9 Feb 2021
- Primary completion28 Jul 2021
- Study completion28 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin CancerStudies 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
- 373 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brugmann University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laurence Postelmans, Brugmann University Hospital
- Investigators
- Nosria Boulakhrif, Principal investigator, CHU Brugmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04886908
- Sponsor's protocol ID
- CHUB-BOULAKHRIF
- Status last verified
- Mar 2022
- First submitted
- 6 May 2021
- Last updated
- 8 Mar 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 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Retrospective Analysis of Skin Tumors of the Eyelids and Face in 2 Brussels University Hospitals Over 5 Years in Dermatology or Ophthalmology
- ClinicalTrials.gov ID
- NCT04886908
- Acronym / sponsor ID
- CHUB-BOULAKHRIF
- Conditions
- Skin Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 373 participants (actual)
- Lead sponsor
- Brugmann University HospitalUniversity, hospital or other
- Study start
- 9 Feb 2021 (actual)
- Primary completion
- 28 Jul 2021 (actual)
- Study completion
- 28 Jul 2021 (actual)
- First posted
- 14 May 2021 (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.
Skin cancers are the most common of all cancers. Their incidence has increased sharply over the decades.This increase in incidence partly reflects an aging population and behavioral patterns such as repeated exposure to the sun. Indeed, exposure to UV rays is the predominant factor involved in the pathogenesis of these tumors, hence the fact that they mainly develop in photo-exposed regions such as the cephalic extremity.
The objective of this study is to provide an epidemiological analysis of tumors in the populations of both CHU Brugmann and St Pierre hospitals.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Identification of all patients who have undergone surgical excision of benign or malignant facial and/or eyelid tumors over the past 5 years in the Dermatology and/or Ophthalmology Departments of the CHU Saint-Pierre and CHU Brugmann hospitals.
Key inclusion criteria (1 listed)
- Final diagnosis confirmed by pathological analysis, epidemiological and clinical information available from patients.
Key exclusion criteria (1 listed)
- Patients who have expressed a refusal to access their medical file or incomplete data will not be taken into account.
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 | – |
Primary outcome
Age
Time frame: 5 minutes
Age of the patient at the time of diagnose
Sex
Time frame: 5 minutes
Sex of the patient
Name of the department in which the patient is followed
Time frame: 5 minutes
Ophthalmology-CHU Brugmann hospital or Dermatology-CHU Brugmann hospital or Ophthalmology- CHU St Pierre Hospital or Dermatology-CHU St Pierre Hospital
Tumor anatomical location
Time frame: 5 minutes
Eyelids are distributed in their different regions: internal cantus and external cantus, upper eyelid and lower eyelid. Same for the face: ears, zygomatic, forehead, temples, cheeks, nose, upper lip, lower lip, chin, nasolabial fold, preauricular area, retroauricular area, brow bone.
Tumor size
Time frame: 5 minutes
Tumor size in millimeters
Laterality
Time frame: 5 minutes
Laterality: left, right, median
Multiple or single tumor
Time frame: 5 minutes
Multiple or single tumor
Primitive tumor or recidive
Time frame: 5 minutes
Primitive tumor or recidive
Risk factor: phototype
Time frame: 5 minutes
Phototype 1 to 6 on the Fitzpatrick scale. The Fitzpatrick scale is a numerical classification schema for human skin color. Type 1 is pale skin that always burns, never tans and type 6 is deeply pigmented dark brown to darkest brown skin that never burns.
Risk factor: immunosuppression (yes/no)
Time frame: 5 minutes
Pathogenic or iatrogenic, history of malignant skin tumors other than melanoma, personal or family history of melanoma
Risk factor: keratosis
Time frame: 5 minutes
Actinic keratosis of the face
Risk factor: solar exposition (yes/no)
Time frame: 5 minutes
Lived in a sunny European country> 1 year, lived in a sunny country outside Europe> 1 year, sunbed use> 1 session, history of solar erythema during childhood.
Diagnosis
Time frame: 5 minutes
Time between the appearance of the tumor and the first consultation
Locoregional extension report (yes/no)
Time frame: 5 minutes
Locoregional extension report (yes/no)
Histological diagnosis of the tumor
Time frame: 5 minutes
Histological diagnosis of the tumor
Healthy or invaded margins
Time frame: 5 minutes
Healthy or invaded margins
Superficial or infiltrating tumor
Time frame: 5 minutes
Superficial or infiltrating tumor
Diagnostic method
Time frame: 5 minutes
Diagnostic method: curettage, punch, biopsy, flattening
Surgical management method
Time frame: 5 minutes
Biopsy resection, plasty, graft, second-line healing, enucleation, additional treatment: radiotherapy, immunotherapy, liquid nitrogen
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 8 Mar 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.
Nosria Boulakhrif 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 Skin Cancer, run by Brugmann University Hospital 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 1 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 8 Mar 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?
Age (time frame: 5 minutes). The study lists 19 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 8 Mar 2022; AzTrials last refreshed its copy on 8 Nov 2026.