SarcoidosisNCT01809145
Testing Hypersensitivity to Metals in Sarcoidosis Patients by Applying the MELISA Test.
A study testing MELISA test in people with Sarcoidosis, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to apply the MELISA test, that diagnose hypersensitivity to metals, in Sarcoidosis patients with occupational exposure. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sarcoidosis
- What is being tested?
- MELISA test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2013to Dec 2013
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Biopsy confirmed sarcoidosis Granulomatous disease Occupational anamnesis with exposure to metals
Who cannot join
- Patients with interstitial disease No occupational anamnesis
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Tel-Aviv Sourasky Medical Center
Tel Aviv, Israel, 64239
Elizabeth Fireman, PhD, 972-36973988, fireman@tlvmc.gov.il
Yifat Alcalay, PhD, 973-36973749, yifatal@tlvmc.gov.il
About this study
Official title: Testing Hypersensitivity to Metals in Sarcoidosis Patients With Occupational Exposure, Using the MELISA Test.
The purpose of this study is to apply the MELISA test, that diagnose hypersensitivity to metals, in Sarcoidosis patients with occupational exposure.
Read the detailed description
Peripheral blood from sarcoidosis patients with occupational anamnesis that involves exposure to metals will be sent to MELISA Medica in Stockholm Sweden. The MELISA test will examine hypersensitivity to metals that can be related to the granulomatous response of sarcoidosis.
- Conditions
- Sarcoidosis
- Being tested
- MELISA test
- Keywords
- sarcoidosis, occupational exposure, MELISA
- Medical subject headings
- Sarcoidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MELISA testOther
MELISA test for hypersensitivity to metals in sarcoidosis
| Study group | Role | What they receive |
|---|---|---|
| metal hypersensitivity | Other | peripheral blood test for metal hypersensitivity (MELISA test) Receives: Other: MELISA test |
What is being measured
The primary outcome is the main question the study is designed to answer.
MELISA test
Using the MELISA test in peripheral blood, in order to find hypersensitivity to metals that can be related to the granulomatous response of sarcoidosis.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcoidosisStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Elizabeth Fireman, PhD, Principal investigator, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01809145
- Sponsor's protocol ID
- TASMC-13-LF-0683-CTIL
- Status last verified
- Mar 2013
- First submitted
- 7 Mar 2013
- Last updated
- 12 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing Hypersensitivity to Metals in Sarcoidosis Patients With Occupational Exposure, Using the MELISA Test.
- ClinicalTrials.gov ID
- NCT01809145
- Acronym / sponsor ID
- TASMC-13-LF-0683-CTIL
- Conditions
- Sarcoidosis
- Keywords
- sarcoidosis, occupational exposure, MELISA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Mar 2013
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 12 Mar 2013 (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 purpose of this study is to apply the MELISA test, that diagnose hypersensitivity to metals, in Sarcoidosis patients with occupational exposure.
Detailed description
Peripheral blood from sarcoidosis patients with occupational anamnesis that involves exposure to metals will be sent to MELISA Medica in Stockholm Sweden. The MELISA test will examine hypersensitivity to metals that can be related to the granulomatous response of sarcoidosis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| metal hypersensitivity | Other | Other: MELISA testperipheral blood test for metal hypersensitivity (MELISA test) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Biopsy confirmed sarcoidosis Granulomatous disease Occupational anamnesis with exposure to metals
Key exclusion criteria (1 listed)
- Patients with interstitial disease No occupational anamnesis
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 |
|---|---|---|
| MELISA testMELISA test for hypersensitivity to metals in sarcoidosis | Other | metal hypersensitivity |
Primary outcome
MELISA test
Time frame: 30 days
Using the MELISA test in peripheral blood, in order to find hypersensitivity to metals that can be related to the granulomatous response of sarcoidosis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2013.
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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.
Elizabeth Fireman, PhD principal investigator
Tel-Aviv Sourasky Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MELISA test in people with Sarcoidosis, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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: status not confirmed, as of the sponsor's last update on 12 Mar 2013. 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 Israel. 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 Elizabeth Fireman, PhD (972-36973988, fireman@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MELISA test (time frame: 30 days). 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 12 Mar 2013.