Skip to main content
OpenTrials
Completed

NCT Number: NCT05613244

Descriptive Study of a Cohort of Orbital Solitary Fibrous Tumors

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Orbital Tumor Bone Diseases Bone Neoplasms Eye Diseases Eye Neoplasms Musculoskeletal Diseases Neoplasms Neoplasms by Site Orbital Diseases Orbital Neoplasms Skull Neoplasms

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Fondation A. de Rothschild

Paris, 75019, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

phone call

Other

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

Primary outcomes

  1. Population characteristics

    Time frame: inclusion

    descriptive statistics of each variable: age, sex, symptoms, duration of symptoms

  2. Medical history

    Time frame: inclusion

    descriptive statistics of each variable: history of previous biopsy or excision, previous intraoperative data,previous pathological data

  3. Radiological lesion features

    Time frame: inclusion

    descriptive statistics of each variable: laterality, orbital location, size and characteristics on preoperative orbital imaging

  4. 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

  5. Intraoperative data

    Time frame: inclusion

    descriptive statistics of each variable: complete or incomplete surgical removal, surgical removal 'in toto' or by fragments

Sponsors and collaborators

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Network

Registry information

Official study title

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

Acronym: TFS-ORB

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Nov 14, 2022
Registry last updated
Oct 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.