Sjogrens SyndromeNCT01470638
A Study of Flt3-Ligand Levels in Sjögrens Syndrome
An observational study of Sjogrens Syndrome, run by Göteborg University at 1 site in Sweden.
Trial summary
The study aims to correlate levels of Flt3-ligand in Cerebrospinal Fluid (CSF) and serum to markers for inflammation and degeneration in patients with primary Sjogrens syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sjogrens Syndrome
- How many people
- 30 participants
- Where
- 1 siteSweden
- Study dates
- Jun 2009to Apr 2019
- 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: The rheumatology clinic at Sahlgrenska University hospital, Gothenburg, Sweden
Who may be able to join
- fulfill the ACR-criteria for primary Sjogrens syndrome,
- age above 18 years old
Who cannot join
- other CNS-disease
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Dept of Rheumatology, Sahlgrenska University Hospital
Gothenburg, 413 46
About this study
Official title: Analyzes of Cerebrospinal Fluid in Autoimmune Systemic Diseases
The study aims to correlate levels of Flt3-ligand in Cerebrospinal Fluid (CSF) and serum to markers for inflammation and degeneration in patients with primary Sjogrens syndrome.
Read the detailed description
The study aims to correlate levels of Flt3-ligand in CSF and serum to markers for inflammation and degeneration in patients with primary Sjogrens syndrome.
- Conditions
- Sjogrens Syndrome
- Keywords
- Flt3-L, CSF
- Medical subject headings
- Sjogren's Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlate levels of Flt3-ligand in Cerebrospinal Fluid (CSF) and serum to markers for inflammation and degeneration in patients with primary Sjogrens syndrome
Measured: June 2009 - June 2015
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2011 (estimated)
- Study startJun 2009
- Primary completionApr 2019
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sjogrens SyndromeStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe 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
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01470638
- Sponsor's protocol ID
- Flt3-L SS
- Status last verified
- Apr 2019
- First submitted
- 9 Nov 2011
- Last updated
- 24 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analyzes of Cerebrospinal Fluid in Autoimmune Systemic Diseases
- ClinicalTrials.gov ID
- NCT01470638
- Acronym / sponsor ID
- Flt3-L SS
- Conditions
- Sjogrens Syndrome
- Keywords
- Flt3-L, CSF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Apr 2019 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 11 Nov 2011 (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.
The study aims to correlate levels of Flt3-ligand in Cerebrospinal Fluid (CSF) and serum to markers for inflammation and degeneration in patients with primary Sjogrens syndrome.
Detailed description
The study aims to correlate levels of Flt3-ligand in CSF and serum to markers for inflammation and degeneration in patients with primary Sjogrens syndrome.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The rheumatology clinic at Sahlgrenska University hospital, Gothenburg, Sweden
Key inclusion criteria (2 listed)
- fulfill the ACR-criteria for primary Sjogrens syndrome,
- age above 18 years old
Key exclusion criteria (1 listed)
- other CNS-disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlate levels of Flt3-ligand in Cerebrospinal Fluid (CSF) and serum to markers for inflammation and degeneration in patients with primary Sjogrens syndrome
Time frame: June 2009 - June 2015
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 24 Apr 2019.
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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 Sjogrens Syndrome, run by Göteborg University at 1 site in Sweden.
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 2 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 24 Apr 2019. 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 Sweden. 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?
Correlate levels of Flt3-ligand in Cerebrospinal Fluid (CSF) and serum to markers for inflammation and degeneration in patients with primary Sjogrens syndrome (time frame: June 2009 - June 2015). 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 24 Apr 2019.