NCT05613244

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 4, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 14, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

January 26, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2023

Completed
Last Updated

October 23, 2023

Status Verified

October 1, 2023

Enrollment Period

6 months

First QC Date

November 4, 2022

Last Update Submit

October 18, 2023

Conditions

Orbital Tumor

Outcome Measures

Primary Outcomes (5)

  • Population characteristics

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

    inclusion

  • Medical history

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

    inclusion

  • Radiological lesion features

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

    inclusion

  • 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

  • Intraoperative data

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

    inclusion

Study Arms (1)

Patients with Orbital Solitary Fibrous Tumors

Other: Phone call

Interventions

Phone callOTHER

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

Patients with Orbital Solitary Fibrous Tumors

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with an orbital solitary fibrous tumor

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Fondation A. de Rothschild

Paris, 75019, France

Location

MeSH Terms

Conditions

Orbital Neoplasms

Condition Hierarchy (Ancestors)

Skull NeoplasmsBone NeoplasmsNeoplasms by SiteNeoplasmsEye NeoplasmsBone DiseasesMusculoskeletal DiseasesEye DiseasesOrbital Diseases

Study Officials

  • Natasha MAMBOUR

    Hôpital Fondation A. de Rothschild

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2022

First Posted

November 14, 2022

Study Start

January 26, 2023

Primary Completion

July 25, 2023

Study Completion

July 25, 2023

Last Updated

October 23, 2023

Record last verified: 2023-10

Locations

FR(1)