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Investigation of Immune Disorders and Deficiencies

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01981785
First Posted: November 13, 2013
Last Update Posted: April 4, 2017
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. Read our disclaimer for details.
Information provided by (Responsible Party):
Oral Alpan, O & O Alpan LLC
  Purpose

The immune system is an intricate system comprised of specialized cells, proteins, tissues and organs. Proper functioning is critical to the body's ability to defend itself against harmful pathogens. Immunological disorders and deficiencies are defects in the immune system that lead to abnormal immune responses. Abnormal immune responses could be derived from immune deficiencies, dysregulations or hypersensitivities.

The overall goal of this research study is to identify the mechanisms of primary immune deficiencies and immune disorders at the genetic, cellular and molecular level, using novel analytic techniques to be performed on immune cells derived from blood samples. The knowledge gained from the aims of this study could lead to better diagnostics and identify novel targets for therapeutic interventions.


Condition
Primary Immune Deficiencies Autoimmune Diseases Inflammatory Diseases Common Variable Immune Deficiencies Hypogammaglobulinemia

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Investigation of Molecular, Genetic and Cellular Mechanisms of Human Immune Disorders and Deficiencies

Resource links provided by NLM:


Further study details as provided by Oral Alpan, O & O Alpan LLC:

Primary Outcome Measures:
  • Genetic variants [ Time Frame: 10 years ]
    To elucidate genetic variants associated with various previously identified immune disorders to include but not limited to immune dysregulations, hypersensitivities, inflammatory conditions and deficiencies.


Secondary Outcome Measures:
  • Pathogenesis [ Time Frame: 10 years ]
    To further elucidate pathogenesis of previously discovered immune disorders or subjects with suspected allergic/immunological disorders using cell surface and intracellular staining techniques using flow cytometry.


Biospecimen Retention:   Samples With DNA
Blood

Enrollment: 343
Study Start Date: December 2012
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
Immune deficiencies/Immune disorders
Patients with abnormal immune responses or potential primary immune deficiencies or immune disorders (allergies, autoimmune diseases) will be enrolled as the study group.
No prior immune abnormalities
Patients with no prior immune abnormalities will be enrolled as the control group.

Detailed Description:
Primary immunodeficiency diseases (PID) represent a class of disorders in which there is an instrinsic defect in the human immune system. The PID could be caused by defects or perturbations in either the innate or adaptive immune cells, such as B cell defects which result in lack of antibodies. Research in this topic remains a difficult feat due factors such as genetic heterogeneity and the gene-environment interface. Limitations of standard of care testing leads to many patients with immunological problems to be undiagnosed. In addition to the variety of primary immune deficiencies, there are large number of immune system disorders due to various perturbations in the immunological components that cause diseases with much greater prevalence such as autoimmune diseases, lymphoproliferative diseases, chronic inflammation and certain cancers. The causes of these immune disorders are typically more complex than PID but there are also many overlaps in immune hyper-activation and deficiency.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with abnormal immune responses or potential PID or immune disorders (allergies, autoimmune diseases) will be enrolled as the study group and patients with no prior immune abnormalities will be enrolled as the control group.
Criteria

Inclusion Criteria:

  • Subject is greater than or equal to 1 day of age and less than or equal to 100years of age
  • Signed Informed Consent/Assent
  • Subject is able and willing to comply with study protocol requirements
  • From clinical or blood laboratory findings subject has evidence of immune abnormalities (or no immune abnormalities in the case of controls) or immune-mediated disease.

Exclusion Criteria:

  • Risk factors for donating blood (such as anemia or blood clotting disorders)
  Contacts and Locations
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): NCT01981785


Locations
United States, Virginia
O&O Alpan LLC
Fairfax, Virginia, United States, 22030
Sponsors and Collaborators
O & O Alpan LLC
Investigators
Principal Investigator: Oral Alpan, MD O & O Alpan LLC
  More Information

Additional Information:
Responsible Party: Oral Alpan, Principal Investigator, O & O Alpan LLC
ClinicalTrials.gov Identifier: NCT01981785     History of Changes
Other Study ID Numbers: 12-CFCT-04
First Submitted: May 6, 2013
First Posted: November 13, 2013
Last Update Posted: April 4, 2017
Last Verified: April 2017

Keywords provided by Oral Alpan, O & O Alpan LLC:
Primary immune deficiencies
Autoimmune diseases
Inflammatory diseases
Common variable immune deficiencies
Primary Immunodeficiencies
Immunoglobulin
IgG
IVIG
Recurrent Infections

Additional relevant MeSH terms:
Autoimmune Diseases
Immunologic Deficiency Syndromes
Agammaglobulinemia
Immune System Diseases
Common Variable Immunodeficiency
Blood Protein Disorders
Hematologic Diseases
Lymphoproliferative Disorders
Lymphatic Diseases