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Analysis of B Cells From Autoimmune Individuals

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02747277
Recruitment Status : Recruiting
First Posted : April 21, 2016
Last Update Posted : November 2, 2021
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Study Description
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Brief Summary:
This observational study aims at finding out if individual with autoimmunity exhibit increased numbers of B cells that express two types (instead of one type) of antibodies, and if B cells of individuals genetically susceptible to autoimmunity display defects in the biological process of tolerance, which removes B cells that participate in autoimmunity.

Condition or disease
Lupus Erythematosus Rheumatoid Arthritis Type 1 Diabetes

Detailed Description:
Peripheral blood B cells of SLE patients are analyzed by flow cytometry to determine the frequency of B cells co-expressing immunoglobulin kappa an lambda light chains. This frequency is correlated to the disease activity.
Study Design
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Analysis of B Cells From Autoimmune Individuals
Study Start Date : May 2016
Estimated Primary Completion Date : May 2026
Estimated Study Completion Date : May 2026

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Frequency of kappa to lambda ratios of B cells in blood of autoimmune adults [ Time Frame: 1 day ]
    For peripheral adult blood, the main outcome measure is the frequency of κ/λ (kappa to lambda ratios) dual immunoglobulin B cells within the overall B (CD19+ or CD20+) cell population. The collected data will be aggregated as the average frequency of κ/λ B cells in subjects with autoimmunity relative to healthy controls.

  2. Frequency of CD19 and IgM low B cells in cord blood of babies born from autoimmune mothers [ Time Frame: 1 day ]
    For cord blood samples, the main outcome measurement is the frequency of B cells that express both low levels of CD19 and IgM within the total (CD19+ or CD20+) B cell population. The collected data will be aggregated as the average frequency of CD19low/IgMlow B cells in subjects that were born from autoimmune mothers relative to those born from healthy mothers. Moreover, data will also be stratified in respect to the presence or absence of the PTPN22-R620W allele, which is a risk allele for autoimmunity.


Biospecimen Retention:   Samples With DNA
whole blood, umbilical cord blood

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult males and females with a diagnoses of lupus erythematosus, rheumatoid arthritis, or type 1 diabetes
Criteria

Inclusion Criteria:

  • Adult Males and Females diagnosed with Lupus;

  • Adult Females who are pregnant and diagnosed with:

    • lupus erythematosus
    • rheumatoid arthritis, or
    • type 1 diabetes.

Exclusion Criteria:

  • Adult males or adult females treated with B-cell depletion therapies.
Contacts and Locations
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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): NCT02747277


Contacts
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Contact: Roberta Pelanda, PhD 303-724-8666 roberta.pelanda@ucdenver.edu

Locations
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United States, Colorado
University of Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Roberta Pelanda, PhD    303-724-8666    Roberta.Pelanda@ucdenver.edu   
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Roberta Pelanda, PhD University of Colorado, Denver
More Information
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02747277    
Other Study ID Numbers: 16-0541
UL1TR001082 ( U.S. NIH Grant/Contract )
First Posted: April 21, 2016    Key Record Dates
Last Update Posted: November 2, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: De-identified individual participant data will be presented at conferences and eventually published in peer-reviewed publication.
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Diabetes Mellitus, Type 1
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
 Autoimmune Diseases
Immune System Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases