Comparative Retrospective Analysis of Skin Tumors of the Eyelids and Face in 2 Brussels University Hospitals Over 5 Years in Dermatology or Ophthalmology

March 7, 2022 updated by: Laurence Postelmans, Brugmann University Hospital

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
373

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1020
        • CHU Brugmann

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

Final diagnosis confirmed by pathological analysis, epidemiological and clinical information available from patients.

Exclusion Criteria:

Patients who have expressed a refusal to access their medical file or incomplete data will not be taken into account.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Age
Time Frame: 5 minutes
Age of the patient at the time of diagnose
5 minutes
Sex
Time Frame: 5 minutes
Sex of the patient
5 minutes
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
5 minutes
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.
5 minutes
Tumor size
Time Frame: 5 minutes
Tumor size in millimeters
5 minutes
Laterality
Time Frame: 5 minutes
Laterality: left, right, median
5 minutes
Multiple or single tumor
Time Frame: 5 minutes
Multiple or single tumor
5 minutes
Primitive tumor or recidive
Time Frame: 5 minutes
Primitive tumor or recidive
5 minutes
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.
5 minutes
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
5 minutes
Risk factor: keratosis
Time Frame: 5 minutes
Actinic keratosis of the face
5 minutes
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.
5 minutes
Diagnosis
Time Frame: 5 minutes
Time between the appearance of the tumor and the first consultation
5 minutes
Locoregional extension report (yes/no)
Time Frame: 5 minutes
Locoregional extension report (yes/no)
5 minutes
Histological diagnosis of the tumor
Time Frame: 5 minutes
Histological diagnosis of the tumor
5 minutes
Healthy or invaded margins
Time Frame: 5 minutes
Healthy or invaded margins
5 minutes
Superficial or infiltrating tumor
Time Frame: 5 minutes
Superficial or infiltrating tumor
5 minutes
Diagnostic method
Time Frame: 5 minutes
Diagnostic method: curettage, punch, biopsy, flattening
5 minutes
Surgical management method
Time Frame: 5 minutes
Biopsy resection, plasty, graft, second-line healing, enucleation, additional treatment: radiotherapy, immunotherapy, liquid nitrogen
5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Brugmann University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nosria Boulakhrif, CHU Brugmann

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 9, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 28, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 28, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 6, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 14, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 8, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CHUB-BOULAKHRIF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Skin Cancer

Clinical Trials on Data extraction from medical files

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings