Testing Hypersensitivity to Metals in Sarcoidosis Patient... | NCT01809145

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

NCT01809145

Sponsor

Tel-Aviv Sourasky Medical Center

Status

Unknown status

Last Update Posted

Mar 12, 2013Estimated

Enrollment

10Estimated

Phase

Not Applicable

Conditions

Sarcoidosis

Interventions

MELISA test

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2013

Primary Completion Date

Dec 2013Estimated

Completion Date

Dec 2013Estimated

First Submitted Date

Mar 7, 2013

First Submission Date that Met QC Criteria

Mar 10, 2013

First Posted Date

Mar 12, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 10, 2013

Last Update Posted Date

Mar 12, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
metal hypersensitivity	Other	peripheral blood test for metal hypersensitivity (MELISA test)	Other: MELISA test

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MELISA test	Other	MELISA test for hypersensitivity to metals in sarcoidosis	metal hypersensitivity

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	30 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Biopsy confirmed sarcoidosis Granulomatous disease Occupational anamnesis with exposure to metals

Exclusion Criteria:

Patients with interstitial disease No occupational anamnesis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Elizabeth Fireman, PhD	Contact	972-36973988		fireman@tlvmc.gov.il

Overall Officials

Name	Affiliation	Role
Elizabeth Fireman, PhD	Tel-Aviv Sourasky Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tel-Aviv Sourasky Medical Center	Recruiting	Tel Aviv	Israel	64239	Israel

Condition Browse Module

MeSH Terms

ID	Term
D012507	Sarcoidosis

Ancestor Terms

ID	Term
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases
D006968	Hypersensitivity, Delayed

Browse Leaves

Not provided

Browse Branches

Not provided