NCT01809145

Brief Summary

The purpose of this study is to apply the MELISA test, that diagnose hypersensitivity to metals, in Sarcoidosis patients with occupational exposure.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

March 7, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 12, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

March 12, 2013

Status Verified

March 1, 2013

Enrollment Period

9 months

First QC Date

March 7, 2013

Last Update Submit

March 10, 2013

Conditions

Sarcoidosis

Keywords

sarcoidosisoccupational exposureMELISA

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

metal hypersensitivity

OTHER

peripheral blood test for metal hypersensitivity (MELISA test)

Other: MELISA test

Interventions

MELISA testOTHER

MELISA test for hypersensitivity to metals in sarcoidosis

metal hypersensitivity

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Biopsy confirmed sarcoidosis Granulomatous disease Occupational anamnesis with exposure to metals

You may not qualify if:

  • Patients with interstitial disease No occupational anamnesis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel-Aviv Sourasky Medical Center

Tel Aviv, Israel, 64239, Israel

RECRUITING

MeSH Terms

Conditions

Sarcoidosis

Condition Hierarchy (Ancestors)

Lymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesHypersensitivity, DelayedHypersensitivityImmune System Diseases

Study Officials

  • Elizabeth Fireman, PhD

    Tel-Aviv Sourasky Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth Fireman, PhD

CONTACT

972-36973988fireman@tlvmc.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2013

First Posted

March 12, 2013

Study Start

March 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

March 12, 2013

Record last verified: 2013-03

Locations

IL(1)