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

October 18, 2023 updated by: Fondation Ophtalmologique Adolphe de Rothschild

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Paris, France, 75019
        • Hôpital Fondation A. de Rothschild
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with an orbital solitary fibrous tumor

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Other

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 26, 2023

Primary Completion (Actual)

July 25, 2023

Study Completion (Actual)

July 25, 2023

Study Registration Dates

First Submitted

November 4, 2022

First Submitted That Met QC Criteria

November 4, 2022

First Posted (Actual)

November 14, 2022

Study Record Updates

Last Update Posted (Actual)

October 23, 2023

Last Update Submitted That Met QC Criteria

October 18, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMR_2020_36

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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