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Testing Hypersensitivity to Metals in Sarcoidosis Patients by Applying the MELISA Test.

Primary Purpose

Sarcoidosis

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
MELISA test
Sponsored by
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Sarcoidosis focused on measuring sarcoidosis, occupational exposure, MELISA

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Biopsy confirmed sarcoidosis Granulomatous disease Occupational anamnesis with exposure to metals

Exclusion Criteria:

Patients with interstitial disease No occupational anamnesis

Sites / Locations

  • Tel-Aviv Sourasky Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

metal hypersensitivity

Arm Description

peripheral blood test for metal hypersensitivity (MELISA test)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 7, 2013
Last Updated
March 10, 2013
Sponsor
Tel-Aviv Sourasky Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01809145
Brief Title
Testing Hypersensitivity to Metals in Sarcoidosis Patients by Applying the MELISA Test.
Official Title
Testing Hypersensitivity to Metals in Sarcoidosis Patients With Occupational Exposure, Using the MELISA Test.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Unknown status
Study Start Date
March 2013 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tel-Aviv Sourasky Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoidosis
Keywords
sarcoidosis, occupational exposure, MELISA

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
metal hypersensitivity
Arm Type
Other
Arm Description
peripheral blood test for metal hypersensitivity (MELISA test)
Intervention Type
Other
Intervention Name(s)
MELISA test
Intervention Description
MELISA test for hypersensitivity to metals in sarcoidosis
Primary Outcome Measure Information:
Title
MELISA test
Description
Using the MELISA test in peripheral blood, in order to find hypersensitivity to metals that can be related to the granulomatous response of sarcoidosis.
Time Frame
30 days

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Biopsy confirmed sarcoidosis Granulomatous disease Occupational anamnesis with exposure to metals Exclusion Criteria: Patients with interstitial disease No occupational anamnesis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth Fireman, PhD
Phone
972-36973988
Email
fireman@tlvmc.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Fireman, PhD
Organizational Affiliation
Tel-Aviv Sourasky Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tel-Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Fireman, PhD
Phone
972-36973988
Email
fireman@tlvmc.gov.il
First Name & Middle Initial & Last Name & Degree
Yifat Alcalay, PhD
Phone
973-36973749
Email
yifatal@tlvmc.gov.il

12. IPD Sharing Statement

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Testing Hypersensitivity to Metals in Sarcoidosis Patients by Applying the MELISA Test.

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