Descriptive Study of a Cohort of Orbital Solitary Fibrous Tumors

Orbital Tumor Clinical Trial

— TFS-ORB  

Official title:

Orbital Solitary Fibrous Tumors: Description of a Case Series and Study of the Recurrence Rate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05613244
• Other study ID #: NMR_2020_36
• Status: Completed
• Start date: January 26, 2023
• Est. completion date: July 25, 2023

Study information

• Verified date: October 2023
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 25, 2023
• Est. primary completion date: July 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemangiopericytoma
• Orbital Tumor
• Solitary Fibrous Tumors

Intervention

Other:
• Phone call
Patients will be asked to complete a questionnaire via a phone call

Locations

Country	Name	City	State
France	Hôpital Fondation A. de Rothschild	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Population characteristics	descriptive statistics of each variable: age, sex, symptoms, duration of symptoms	inclusion
Primary	Medical history	descriptive statistics of each variable: history of previous biopsy or excision, previous intraoperative data,previous pathological data	inclusion
Primary	Radiological lesion features	descriptive statistics of each variable: laterality, orbital location, size and characteristics on preoperative orbital imaging	inclusion
Primary	Pathological lesion characteristics	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	inclusion
Primary	Intraoperative data	descriptive statistics of each variable: complete or incomplete surgical removal, surgical removal 'in toto' or by fragments	inclusion