Descriptive Study of a Cohort of Orbital Solitary Fibrous Tumors

Completed

• Conditions: Orbital Tumor
• Interventions: Other: Phone call

• Registration Number: NCT05613244
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Brief Summary

Orbital solitary fibrous tumors are rare tumors with an intermediate potential of malignancy. Orbital solitary fibrous tumors' prognostic criteria are still poorly understood.

Some patients with orbital solitary fibrous tumors have been treated at the Adolphe de Rothschild Foundation Hospital. This cohort will be studied to describe the recurrence rate and to identify predictive factors of recurrence or metastasis.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-04
• Study First Submitted QC: 2022-11-04
• Study First Posted: 2022-11-14
• Study Start: 2023-01-26
• Primary Completion: 2023-07-25
• Study Completion: 2023-07-25
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-18
• Last Update Posted: 2023-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Patients treated at the Adolphe de Rothschild foundation hospital for an orbital solitary fibrous tumor between 01/01/2014 and 09/30/2020

Exclusion Criteria

• Opposition of the patient (or of the relative if the patient is deceased)
• Patients benefiting from a legal protection measure
• Pregnant or breastfeeding woman

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with Orbital Solitary Fibrous Tumors	Phone call	-

Primary Outcome Measures

Name	Time	Method
Population characteristics	inclusion	descriptive statistics of each variable: age, sex, symptoms, duration of symptoms
Intraoperative data	inclusion	descriptive statistics of each variable: complete or incomplete surgical removal, surgical removal 'in toto' or by fragments
Pathological lesion characteristics	inclusion	descriptive statistics of each variable: presence of necrosis, presence of epithelioid morphology of these cells, presence of cellular atypia, description of the mitotic index, immunohistochemical study, proliferation factor
Radiological lesion features	inclusion	descriptive statistics of each variable: laterality, orbital location, size and characteristics on preoperative orbital imaging
Medical history	inclusion	descriptive statistics of each variable: history of previous biopsy or excision, previous intraoperative data,previous pathological data

Trial Locations

Locations (1)

Hôpital Fondation A. de Rothschild; 🇫🇷 Paris, France