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Meir Medical Center Rheumatologic Biobank

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ClinicalTrials.gov Identifier: NCT03473912
Recruitment Status : Recruiting
First Posted : March 22, 2018
Last Update Posted : March 11, 2019
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center

Brief Summary:
Serum, synovial fluid and skin biopsies from patients will be collected to the biobank with rheumatoid diseases. These samples will later be used for clinical and basic research, following approval of each specific study by the IRB. The investigators intend to extract protein, DNA and RNA from each sample.

Condition or disease
Rheumatoid Arthritis Lupus Erythematosus, Systemic Systemic Sclerosis IgG4-related Disease Sjogren's Syndrome

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 20 Years
Official Title: Rheumatologic Biobank for Clinical and Basic Research: Isolation, Extraction and Storage of Protein, DNA and RNA Extracted From Tissues of Patients With Rheumatoid Diseases
Actual Study Start Date : April 16, 2018
Estimated Primary Completion Date : November 2037
Estimated Study Completion Date : November 2037


Group/Cohort
RA patients
before or after medication
Systemic sclerosis patients
before or after medication
IgG4 RD patients
before or after medication
Lupus patients
before or after medication



Primary Outcome Measures :
  1. collecting samples [ Time Frame: 20 years ]
    IgG4-related disease patients


Biospecimen Retention:   Samples With DNA
blood, synovial fluid and skin biopsies.


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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients of our rheumatological clinic which have a rheumatolid condition and are willing to sign an informed consent.
Criteria

Inclusion Criteria:

  • above 18 years of age
  • willing to sign informed consent
  • have a rheumatoid condition

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03473912


Contacts
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Contact: Yair Levy, Prof. 972-9-7471524 levy.yair@clalit.org.il
Contact: Noa Rabinowicz, Dr. 972-9-7471992 noa.rabinowicz@clalit.org.il

Locations
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Israel
Meir Medical Center Recruiting
Kfar Saba, Israel
Contact: Noa Rabinowicz, PhD    972-9-7471992    noa.rabinowicz@clalit.org.il   
Contact: Yair Levy, Prof    972-9-7471936    levy.yair@clalit.org.il   
Sponsors and Collaborators
Meir Medical Center
Investigators
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Principal Investigator: Yair Levy, Prof. Meir Medical Center

Additional Information:

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Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT03473912     History of Changes
Other Study ID Numbers: MMC17-0116CTIL
First Posted: March 22, 2018    Key Record Dates
Last Update Posted: March 11, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: we might share samples (serum, DNA, RNA..) but not patient personal details as the samples will be coded.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Xerostomia
Mouth Diseases
Dry Eye Syndromes
Arthritis, Rheumatoid
Scleroderma, Systemic
Scleroderma, Diffuse
Sjogren's Syndrome
Lupus Erythematosus, Systemic
Immunoglobulin G4-Related Disease
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Skin Diseases
Salivary Gland Diseases
Stomatognathic Diseases
Lacrimal Apparatus Diseases
Eye Diseases