SarcoidosisuveitisNCT02627209
The Serum Angiotensin Converting Enzyme and Lysozyme Levels in Patients Non-infectious and Infectious Uveitis
A study testing spectrophotometric assay and radial immunodiffusion in people with Sarcoidosis and Tuberculosis, run by Ozlem Sahin at 1 site in Turkey (Türkiye).
Trial summary
This study evaluates the significance of differences in serum angiotensin converting enzyme and lysozyme levels of patients with ocular involvement of other autoimmune inflammatory and infectious diseases. Read more about this study
- Who is it for?
- Ages 9 to 86 years
- Conditions the study is for
- Sarcoidosis, Tuberculosis
- What is being tested?
- spectrophotometric assay and radial immunodiffusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jun 2014to Jan 2017
- Phase
- Interventional
- 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 9 to 86 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects have ocular inflammation diagnosed as sarcoidosis, ankylosing spondylitis, behcet's disease
- Subjects have ocular infection diagnosed as tuberculosis and syphilis
- Subjects have refractive errors only
Who cannot join
- Subjects using ACE inhibitors, systemic steroids, immunosuppressive or immunomodulatory therapies
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
DunyaGoz hospital Tunus caddesi no.28 kavaklidere
Çankaya, Ankara, 06450
Ozlem sahin, MD, 90-537-5523064, ozlem1158@yahoo.com
eda karaismailoğlu, MS, 90-533-3097848, edaozturk@yahoo.com
About this study
Official title: Non-infectious and Infectious Uveitis Diagnosis
This study evaluates the significance of differences in serum angiotensin converting enzyme and lysozyme levels of patients with ocular involvement of other autoimmune inflammatory and infectious diseases.
Read the detailed description
Increased serum levels of angiotensin converting enzyme and lysozyme are considered as inflammatory markers for diagnosis of sarcoidosis which is an autoimmune inflammatory disease. Sarcoidosis, ankylosing spondylitis and Behcet's disease are the most common autoimmune inflammatory diseases involving the eye.
Elevated serum angiotensin converting enzyme levels have also been reported in tuberculosis. Syphilis and tuberculosis are the most common infectious diseases involving the eye.
- Conditions
- Sarcoidosis, Tuberculosis
- Being tested
- spectrophotometric assay, radial immunodiffusion
- Keywords
- Angiotensin converting enzyme, Lysozyme, Ankylosing spondylitis, Behcet's disease, Sarcoidosis, Syphilis, Tuberculosis, Ocular inflammation
- Medical subject headings
- Sarcoidosis, Tuberculosis, Spondylitis, Ankylosing, Behcet Syndrome, Syphilis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spectrophotometric assayOther
measurement of enzyme activity in the serum
radial immunodiffusionOther
measurement of the precipitated ring diameters showing enzyme activity in the serum
| Study group | Role | What they receive |
|---|---|---|
| serum angiotensin converting enzyme | Active comparator | spectrophotometric assay Receives: Other: spectrophotometric assay; Other: radial immunodiffusion |
| serum lysozyme | Active comparator | radial immunodiffusion Receives: Other: spectrophotometric assay; Other: radial immunodiffusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of serum angiotensin converting enzyme level
Measured: 1 day
Secondary outcomes (1)
Analysis of serum lysozyme level
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2015 (estimated)
- Study startJun 2014
- Primary completionFeb 2016 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SarcoidosisStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ozlem Sahin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ozlem Sahin, Dünyagöz Hospital
- Investigators
- Ioannis Pallikaris, MD, Study chair, DunyaGoz Hospital, Etiler, yanarsu sokak no.1 besiktaş Istanbul Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02627209
- Sponsor's protocol ID
- DGH-070
- Acronym
- uveitis
- Status last verified
- Dec 2015
- First submitted
- 26 Nov 2015
- Last updated
- 10 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Birnbaum AD, Oh FS, Chakrabarti A, Tessler HH, Goldstein DA. Clinical features and diagnostic evaluation of biopsy-proven ocular sarcoidosis. Arch Ophthalmol. 2011 Apr;129(4):409-13. doi: 10.1001/archophthalmol.2011.52.
PubMed 21482866Sen DK, Sarin GS. Immunoassay of serum muramidase (lysozyme) in ocular diseases. Indian J Ophthalmol. 1987;35(5-6):103-7.
PubMed 3508756Sahin O, Ziaei A, Karaismailoglu E, Taheri N. The serum angiotensin converting enzyme and lysozyme levels in patients with ocular involvement of autoimmune and infectious diseases. BMC Ophthalmol. 2016 Feb 16;16:19. doi: 10.1186/s12886-016-0194-4.
PubMed 26879979
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-infectious and Infectious Uveitis Diagnosis
- ClinicalTrials.gov ID
- NCT02627209
- Acronym / sponsor ID
- uveitis / DGH-070
- Conditions
- Sarcoidosis, Tuberculosis
- Keywords
- Angiotensin converting enzyme, Lysozyme, Ankylosing spondylitis, Behcet's disease, Sarcoidosis, Syphilis, Tuberculosis, Ocular inflammation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Ozlem SahinUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 10 Dec 2015 (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.
This study evaluates the significance of differences in serum angiotensin converting enzyme and lysozyme levels of patients with ocular involvement of other autoimmune inflammatory and infectious diseases.
Detailed description
Increased serum levels of angiotensin converting enzyme and lysozyme are considered as inflammatory markers for diagnosis of sarcoidosis which is an autoimmune inflammatory disease. Sarcoidosis, ankylosing spondylitis and Behcet's disease are the most common autoimmune inflammatory diseases involving the eye.
Elevated serum angiotensin converting enzyme levels have also been reported in tuberculosis. Syphilis and tuberculosis are the most common infectious diseases involving the eye.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| serum angiotensin converting enzyme | Active comparator | Other: spectrophotometric assay, Other: radial immunodiffusionspectrophotometric assay |
| serum lysozyme | Active comparator | Other: spectrophotometric assay, Other: radial immunodiffusionradial immunodiffusion |
Who may qualify
- Ages
- 9 to 86 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects have ocular inflammation diagnosed as sarcoidosis, ankylosing spondylitis, behcet's disease
- Subjects have ocular infection diagnosed as tuberculosis and syphilis
- Subjects have refractive errors only
Key exclusion criteria (1 listed)
- Subjects using ACE inhibitors, systemic steroids, immunosuppressive or immunomodulatory therapies
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 |
|---|---|---|
| spectrophotometric assaymeasurement of enzyme activity in the serum | Other | serum angiotensin converting enzyme, serum lysozyme |
| radial immunodiffusionmeasurement of the precipitated ring diameters showing enzyme activity in the serum | Other | serum angiotensin converting enzyme, serum lysozyme |
Primary outcome
Analysis of serum angiotensin converting enzyme level
Time frame: 1 day
1 secondary outcome
Analysis of serum lysozyme level
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2015.
- Results publication: PubMed 21482866Birnbaum AD, Oh FS, Chakrabarti A, Tessler HH, Goldstein DA. Clinical features and diagnostic evaluation of biopsy-proven ocular sarcoidosis. Arch Ophthalmol. 2011 Apr;129(4):409-13. doi: 10.1001/archophthalmol.2011.52.
- Results publication: PubMed 3508756Sen DK, Sarin GS. Immunoassay of serum muramidase (lysozyme) in ocular diseases. Indian J Ophthalmol. 1987;35(5-6):103-7.
- Derived from this study: PubMed 26879979Sahin O, Ziaei A, Karaismailoglu E, Taheri N. The serum angiotensin converting enzyme and lysozyme levels in patients with ocular involvement of autoimmune and infectious diseases. BMC Ophthalmol. 2016 Feb 16;16:19. doi: 10.1186/s12886-016-0194-4.
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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.
Ioannis Pallikaris, MD study chair
DunyaGoz Hospital, Etiler, yanarsu sokak no.1 besiktaş Istanbul Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing spectrophotometric assay and radial immunodiffusion in people with Sarcoidosis and Tuberculosis, run by Ozlem Sahin at 1 site in Turkey (Türkiye).
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 3 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: status not confirmed, as of the sponsor's last update on 10 Dec 2015. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ozlem sahin, MD (90-537-5523064, ozlem1158@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of serum angiotensin converting enzyme level (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02627209, which also lists 3 linked publications.
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 10 Dec 2015.