Sturge - Weber Syndrome (SWS)NCT00610402
Incidence of Ocular Antibodies in Patients With Sturge - Weber Syndrome (SWS)
An observational study of Sturge - Weber Syndrome (SWS), run by University of California, Irvine at 1 site in United States.
Trial summary
Sturge-Weber Syndrome (SWS) is a neurological disorder characterized at birth by seizures and a large port-wine stain birthmark on the forehead and upper eyelid of one side of the face. SWS is also accompanied by an increased pressure within the eye (glaucoma) which can develop very early in life. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sturge - Weber Syndrome (SWS)
- What is being tested?
- blood sample tear drop sample
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Jun 2008
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: community sample
Who may be able to join
- Male and female volunteers with SWS of all ages
Who cannot join
- Volunteers without SWS
Trial locations and contacts
1 site in 1 country.
United States1 site
Beckman Laser Institute Medical clinic
Irvine, California, 92612
About this study
Sturge-Weber Syndrome (SWS) is a neurological disorder characterized at birth by seizures and a large port-wine stain birthmark on the forehead and upper eyelid of one side of the face. SWS is also accompanied by an increased pressure within the eye (glaucoma) which can develop very early in life.
Glaucoma represents a group of ocular disorders that are characterized by the loss of retinal ganglion cells and their axons, damage to the optic nerve, and gradual loss of visual field. Recently, several studies provided evidence that there is a potential role of the immune system in the pathogenesis of glaucoma.
These findings suggest that there might be changes in systemic humoral immunity possibly underlying the optic neuropathy in at least some glaucoma patients.
Read the detailed description
The ocular antibody profile in patients with SWS is unknown.The researchers want to study on blood and tear drop samples from patients with SWS to determine the incidence of ocular antibodies in patients with this syndrome.
- Conditions
- Sturge - Weber Syndrome (SWS)
- Being tested
- blood sample tear drop sample
- Medical subject headings
- Brain Stem Infarctions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sample tear drop sampleOther
blood sample tear drop sample
| Study group | Role | What they receive |
|---|---|---|
| blood sample tear drop sample | blood sample tear drop sample Receives: Other: blood sample tear drop sample |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2008 (estimated)
- Study startJul 2007
- Primary completionJul 2007
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sturge - Weber Syndrome (SWS)Studies of the same condition, open and under way.
- More trials run by University of California, IrvineThe 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 only
- Time perspective
- Prospective
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- Mainz University
- Responsible party
- Principal investigator, Beckman Laser Institute and Medical Center, University of California, Irvine
- Investigators
- John S Nelson, M.D,PhD, Principal investigator, Beckman Laser Institute University of California Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00610402
- Sponsor's protocol ID
- 20065691
- Status last verified
- Oct 2022
- First submitted
- 25 Jan 2008
- Last updated
- 20 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Ocular Antibodies in Patients With Sturge - Weber Syndrome (SWS)
- ClinicalTrials.gov ID
- NCT00610402
- Acronym / sponsor ID
- 20065691
- Conditions
- Sturge - Weber Syndrome (SWS)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- Mainz University
- Study start
- Jul 2007
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 8 Feb 2008 (estimated)
- 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.
Sturge-Weber Syndrome (SWS) is a neurological disorder characterized at birth by seizures and a large port-wine stain birthmark on the forehead and upper eyelid of one side of the face. SWS is also accompanied by an increased pressure within the eye (glaucoma) which can develop very early in life.
Glaucoma represents a group of ocular disorders that are characterized by the loss of retinal ganglion cells and their axons, damage to the optic nerve, and gradual loss of visual field. Recently, several studies provided evidence that there is a potential role of the immune system in the pathogenesis of glaucoma.
These findings suggest that there might be changes in systemic humoral immunity possibly underlying the optic neuropathy in at least some glaucoma patients.
Detailed description
The ocular antibody profile in patients with SWS is unknown.The researchers want to study on blood and tear drop samples from patients with SWS to determine the incidence of ocular antibodies in patients with this syndrome.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| blood sample tear drop sample | – | Other: blood sample tear drop sampleblood sample tear drop sample |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- community sample
Key inclusion criteria (1 listed)
- Male and female volunteers with SWS of all ages
Key exclusion criteria (1 listed)
- Volunteers without SWS
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 |
|---|---|---|
| blood sample tear drop sampleblood sample tear drop sample | Other | blood sample tear drop sample |
Primary outcome
Not reported in the source record.
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 20 Oct 2022.
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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.
John S Nelson, M.D,PhD principal investigator
Beckman Laser Institute University of California Irvine
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 Sturge - Weber Syndrome (SWS), run by University of California, Irvine at 1 site in United States.
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 1 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 20 Oct 2022. 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 United States. 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.
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 20 Oct 2022.