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Recruiting NCT07120178

Imaging and Evolution of Pigmented Tumors of the Anterior Ocular System in Children

Observational Pigmented Tumours of the Anterior Ocular System in Children

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: slit lamp examination, dermatoscopy examination x20 and x400, confocal microscopy examination.
Who it may be relevant to
Registry conditions: Pigmented Tumours of the Anterior Ocular System in Children. Basic parameters: up to 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

The investigators were interested in pigmented tumours of the anterior segment of the eye in children because there is very little data on their evolution. The nevus is the most common conjunctival tumour. The challenge is to be able to adapt the child's follow-up according to the imaging and avoid an invasive procedure such as surgical excision if the imaging does not find any suspicious cells despite a change in size or colour. This would also make it possible to answer parents' questions about the potential evolution of the tumour. Finally, it would enable the frequency of monitoring to be personalised according to the data analysed. The tests are all non-invasive and painless.

Interventions

  • Other slit lamp examination
    data collected: tumor size, pigmentation, vascularization, cells
  • Other dermatoscopy examination x20 and x400
    data collected: tumor size, pigmentation, vascularization, cells
  • Other confocal microscopy examination
    data collected: tumor size, pigmentation, vascularization, cells

Primary outcome measures

  • The size and pigmentation of the tumor [Time frame: Day 1]
Secondary outcome measures (2)
  • Describe the evolution according to age [Time frame: Day 1]
  • Describe the evolution according to sex [Time frame: Day 1]

Eligibility criteria

Inclusion criteria

  • Patient who had a first dermato-ophthalmological consultation < 18 years old with pigmented tumors of the anterior ocular system

Exclusion criteria

  • patient over 18 years old at first examination

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • CHU Saint-Etienne — Saint-Etienne

Identifiers

NCT: NCT07120178 · IRBN222025/CHUSTE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗