Orbital TumorTFS-ORBNCT05613244
Descriptive Study of a Cohort of Orbital Solitary Fibrous Tumors
An observational study of Orbital Tumor, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Orbital Tumor
- What is being tested?
- Phone call
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 26 Jan 2023to 25 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with an orbital solitary fibrous tumor
Who may be able to join
- Patients treated at the Adolphe de Rothschild foundation hospital for an orbital solitary fibrous tumor between 01/01/2014 and 09/30/2020
Who cannot join
- Opposition of the patient (or of the relative if the patient is deceased)
- Patients benefiting from a legal protection measure
- Pregnant or breastfeeding woman
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Orbital Tumor
- Being tested
- Phone call
- Medical subject headings
- Orbital Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phone callOther
Patients will be asked to complete a questionnaire via a phone call
| Study group | Role | What they receive |
|---|---|---|
| Patients with Orbital Solitary Fibrous Tumors | Not described Receives: Other: Phone call |
What is being measured
The primary outcome is the main question the study is designed to answer.
Population characteristics
descriptive statistics of each variable: age, sex, symptoms, duration of symptoms
Measured: inclusion
Medical history
descriptive statistics of each variable: history of previous biopsy or excision, previous intraoperative data,previous pathological data
Measured: inclusion
Radiological lesion features
descriptive statistics of each variable: laterality, orbital location, size and characteristics on preoperative orbital imaging
Measured: 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
Measured: inclusion
Intraoperative data
descriptive statistics of each variable: complete or incomplete surgical removal, surgical removal 'in toto' or by fragments
Measured: inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start26 Jan 2023
- Primary completion25 Jul 2023
- Study completion25 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orbital TumorStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Natasha MAMBOUR, Principal investigator, Hôpital Fondation A. de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05613244
- Sponsor's protocol ID
- NMR_2020_36
- Acronym
- TFS-ORB
- Status last verified
- Oct 2023
- First submitted
- 4 Nov 2022
- Last updated
- 23 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Orbital Solitary Fibrous Tumors: Description of a Case Series and Study of the Recurrence Rate
- ClinicalTrials.gov ID
- NCT05613244
- Acronym / sponsor ID
- TFS-ORB / NMR_2020_36
- Conditions
- Orbital Tumor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 26 Jan 2023 (actual)
- Primary completion
- 25 Jul 2023 (actual)
- Study completion
- 25 Jul 2023 (actual)
- First posted
- 14 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Orbital Solitary Fibrous Tumors | – | Other: Phone call |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with an orbital solitary fibrous tumor
Key inclusion criteria (1 listed)
- Patients treated at the Adolphe de Rothschild foundation hospital for an orbital solitary fibrous tumor between 01/01/2014 and 09/30/2020
Key exclusion criteria (3 listed)
- Opposition of the patient (or of the relative if the patient is deceased)
- Patients benefiting from a legal protection measure
- Pregnant or breastfeeding woman
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phone callPatients will be asked to complete a questionnaire via a phone call | Other | Patients with Orbital Solitary Fibrous Tumors |
Primary outcome
Population characteristics
Time frame: inclusion
descriptive statistics of each variable: age, sex, symptoms, duration of symptoms
Medical history
Time frame: inclusion
descriptive statistics of each variable: history of previous biopsy or excision, previous intraoperative data,previous pathological data
Radiological lesion features
Time frame: inclusion
descriptive statistics of each variable: laterality, orbital location, size and characteristics on preoperative orbital imaging
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
Intraoperative data
Time frame: inclusion
descriptive statistics of each variable: complete or incomplete surgical removal, surgical removal 'in toto' or by fragments
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Natasha MAMBOUR principal investigator
Hôpital Fondation A. de Rothschild
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Orbital Tumor, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Population characteristics (time frame: inclusion). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.