TFS-ORB: Descriptive Study of a Cohort of Orbital Solitary Fibrous Tumors

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05613244

Collaborator

(none)

Enrollment

Location

5.9

Anticipated Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Orbital Tumor	Other: Phone call

Study Design

Study Type:

Observational

Anticipated Enrollment :

20 participants

Observational Model:

Case-Only

Time Perspective:

Other

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Patients with Orbital Solitary Fibrous Tumors	Other: Phone call Patients will be asked to complete a questionnaire via a phone call

Arm

Intervention/Treatment

Patients with Orbital Solitary Fibrous Tumors

Other: Phone call

Patients will be asked to complete a questionnaire via a phone call

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital Fondation A. de Rothschild	Paris		France	75019

Sponsors and Collaborators

Fondation Ophtalmologique Adolphe de Rothschild

Investigators

Principal Investigator: Natasha MAMBOUR, Hôpital Fondation A. de Rothschild

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fondation Ophtalmologique Adolphe de Rothschild

ClinicalTrials.gov Identifier:

NCT05613244

Other Study ID Numbers:

NMR_2020_36

First Posted:

Nov 14, 2022

Last Update Posted:

Nov 17, 2022

Last Verified:

Nov 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Solitary Fibrous Tumors

Hemangiopericytoma

Study Results

No Results Posted as of Nov 17, 2022