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

NCT07120178 | Recruiting

• 1 other identifier: IRBN222025/CHUSTE
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pigmented Tumours of the Anterior Ocular System in Children

Keywords

pigmented tumours of the anterior ocular system in children; CONJUNCTIVAL TUMORS CHILDREN

Outcome Measures

Primary Outcomes (1)

• The size and pigmentation of the tumor

  Measurement of the size of the tumor with dermatoscopy x20 in mm and pigmentation with the slit lamp as well as dermatoscopy x20 and x400

  Day 1

Secondary Outcomes (2)

• Describe the evolution according to age

  Day 1

• Describe the evolution according to sex

  Day 1

Study Arms (1)

Observational group

Children with pigmented tumors of the anterior ocular system

Other: slit lamp examination; Other: dermatoscopy examination x20 and x400; Other: confocal microscopy examination

Interventions

slit lamp examination OTHER

data collected: tumor size, pigmentation, vascularization, cells

Observational group

dermatoscopy examination x20 and x400 OTHER

data collected: tumor size, pigmentation, vascularization, cells

Observational group

confocal microscopy examination OTHER

data collected: tumor size, pigmentation, vascularization, cells

Observational group

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children with pigmented tumors of the anterior ocular system

You may qualify if:

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

You may not qualify if:

• patient over 18 years old at first examination

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU Saint-Etienne

Saint-Etienne, France

RECRUITING

MeSH Terms

Interventions

Slit Lamp

Intervention Hierarchy (Ancestors)

Ophthalmoscopes; Diagnostic Equipment; Equipment and Supplies

Study Officials

• Jean Luc PERROT, Md, PhD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean Luc PERROT, Md, PhD

CONTACT

(0)477828508; j.luc.perrot@chu-st-etienne.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: August 13, 2025
• Study Start: April 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)