Investigation of Immune Disorders and Deficiencies

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by O & O Alpan LLC
Sponsor:
Information provided by (Responsible Party):
Oral Alpan, O & O Alpan LLC
ClinicalTrials.gov Identifier:
NCT01981785
First received: May 6, 2013
Last updated: November 5, 2013
Last verified: May 2013
  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 O & O Alpan LLC:

Primary Outcome Measures:
  • Genetic variants [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 300
Study Start Date: December 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01981785

Contacts
Contact: Oral Alpan, MD 571-308-1900 zalpan@aol.com
Contact: Chidima Martin, BS 571-308-1905 cmartin@oandoalpan.com

Locations
United States, Virginia
O&O Alpan LLC Recruiting
Fairfax, Virginia, United States, 22030
Contact: Chidima Martin, BS    571-308-1905    cmartin@oandoalpan.com   
Contact: Denise Loizou, RN    571-308-1900    dloizou@oandoalpan.com   
Principal Investigator: Oral Alpan, MD         
Sub-Investigator: Ozlem Goker-Alpan, MD         
Sponsors and Collaborators
O & O Alpan LLC
Investigators
Principal Investigator: Oral Alpan, MD O & O Alpan LLC
  More Information

Additional Information:
No publications provided

Responsible Party: Oral Alpan, Principal Investigator, O & O Alpan LLC
ClinicalTrials.gov Identifier: NCT01981785     History of Changes
Other Study ID Numbers: 12-CFCT-04
Study First Received: May 6, 2013
Last Updated: November 5, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by 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
Immune System Diseases
Common Variable Immunodeficiency
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on September 16, 2014