IgG4-related DiseaseRetroG4NCT03690908
Infraorbital Nerve Involvement on Magnetic Resonance Imaging in IgG4-related Ophthalmic Disease
An observational study of IgG4-related Disease and Orbital Infections, Inflammations and Irritations, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
Infraorbital nerve enlargement (IONE) on magnetic resonance imaging is known to be a possible consequence of IgG4-related ophthalmic disease. However this imaging sign can also be found in other conditions causing orbital inflammation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IgG4-related Disease, Orbital Infections, Inflammations and Irritations
- How many people
- 38 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2016to 1 Dec 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients suffering from non-thyroid, non-lymphoma related orbital inflammation treated in Fondation Rothschild (tertiary ophtalmology facility, Paris, France) from January 2006 through April 2015.
Who may be able to join
- Patient aged 18 and older treated in Fondation Rothschild (tertiary ophthalmology facility, Paris, France) from January 2006 through April 2015
- Presence of a clinical orbital inflammation: mass/swelling, pain, exophthalmos, visual loss, ptosis, or diplopia.
- The presence of at least one pretherapeutic MRI confirming the inflammation of one or more orbital structures: the lacrimal gland, fat, muscles, or infraorbital nerve. The mandatory minimal MRI protocol include the following sequences: T1- and T2-weighted MRI image, in the transverse and coronal plane, and a fat-suppressed T1-weighted image in the coronal plane obtained after intravenous administration of a gadolinium chelate.
- Completion of at least one orbital biopsy with a pathologic examination and an immunohistochemical screen for IgG4.
Who cannot join
- Clinical and biological signs of thyroid-associated orbitopathy
- Histologically proven lymphoma
- Pretherapeutic MRI that is insufficient for an adequate interpretation
- Absence of IgG4 testing in the pathology examination
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Infraorbital Nerve Involvement on Magnetic Resonance Imaging in European Patients With IgG4-related Ophthalmic Disease
Infraorbital nerve enlargement (IONE) on magnetic resonance imaging is known to be a possible consequence of IgG4-related ophthalmic disease. However this imaging sign can also be found in other conditions causing orbital inflammation. This study aims at comparing the frequency of IONE in patients suffering from IgG4-related ophthalmic disease (IgG4-ROD) versus patients suffering from non-IgG4-related ophthalmic disease (non-IgG4-ROD)
- Being tested
- no intervention (descriptive study)
- Medical subject headings
- Immunoglobulin G4-Related Disease, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no intervention (descriptive study)Other
no intervention (descriptive study)
| Study group | Role | What they receive |
|---|---|---|
| IgG4-related orbital inflammation | patients with orbital inflammation and positive IgG4 immunostaining in orbital biopsy Receives: Other: no intervention (descriptive study) | |
| non IgG4-related orbital inflammation | patients with orbital inflammation and negative IgG4 immunostaining in orbital biopsy Receives: Other: no intervention (descriptive study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with infraorbital nerve involvement in magnetic resonance imaging
Measured: Within 2 weeks after the first consultation for orbital inflammation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2018
- Study start1 Mar 2016
- Primary completion1 Nov 2016
- Study completion1 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IgG4-related DiseaseStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03690908
- Sponsor's protocol ID
- NI_2016_1_ALR
- Acronym
- RetroG4
- Status last verified
- Sep 2018
- First submitted
- 26 Sep 2018
- Last updated
- 1 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infraorbital Nerve Involvement on Magnetic Resonance Imaging in European Patients With IgG4-related Ophthalmic Disease
- ClinicalTrials.gov ID
- NCT03690908
- Acronym / sponsor ID
- RetroG4 / NI_2016_1_ALR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 1 Nov 2016 (actual)
- Study completion
- 1 Dec 2016 (actual)
- First posted
- 1 Oct 2018 (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.
Infraorbital nerve enlargement (IONE) on magnetic resonance imaging is known to be a possible consequence of IgG4-related ophthalmic disease. However this imaging sign can also be found in other conditions causing orbital inflammation. This study aims at comparing the frequency of IONE in patients suffering from IgG4-related ophthalmic disease (IgG4-ROD) versus patients suffering from non-IgG4-related ophthalmic disease (non-IgG4-ROD)
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IgG4-related orbital inflammation | – | Other: no intervention (descriptive study)patients with orbital inflammation and positive IgG4 immunostaining in orbital biopsy |
| non IgG4-related orbital inflammation | – | Other: no intervention (descriptive study)patients with orbital inflammation and negative IgG4 immunostaining in orbital biopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients suffering from non-thyroid, non-lymphoma related orbital inflammation treated in Fondation Rothschild (tertiary ophtalmology facility, Paris, France) from January 2006 through April 2015.
Key inclusion criteria (4 listed)
- Patient aged 18 and older treated in Fondation Rothschild (tertiary ophthalmology facility, Paris, France) from January 2006 through April 2015
- Presence of a clinical orbital inflammation: mass/swelling, pain, exophthalmos, visual loss, ptosis, or diplopia.
- The presence of at least one pretherapeutic MRI confirming the inflammation of one or more orbital structures: the lacrimal gland, fat, muscles, or infraorbital nerve. The mandatory minimal MRI protocol include the following sequences: T1- and T2-weighted MRI image, in the transverse and coronal plane, and a fat-suppressed T1-weighted image in the coronal plane obtained after intravenous administration of a gadolinium chelate.
- Completion of at least one orbital biopsy with a pathologic examination and an immunohistochemical screen for IgG4.
Key exclusion criteria (4 listed)
- Clinical and biological signs of thyroid-associated orbitopathy
- Histologically proven lymphoma
- Pretherapeutic MRI that is insufficient for an adequate interpretation
- Absence of IgG4 testing in the pathology examination
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 |
|---|---|---|
| no intervention (descriptive study)no intervention (descriptive study) | Other | IgG4-related orbital inflammation, non IgG4-related orbital inflammation |
Primary outcome
Proportion of patients with infraorbital nerve involvement in magnetic resonance imaging
Time frame: Within 2 weeks after the first consultation for orbital inflammation
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 1 Oct 2018.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 IgG4-related Disease and Orbital Infections, Inflammations and Irritations, 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 4 inclusion and 4 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 1 Oct 2018. 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?
Proportion of patients with infraorbital nerve involvement in magnetic resonance imaging (time frame: Within 2 weeks after the first consultation for orbital inflammation). 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 1 Oct 2018.