Investigation of Immune Disorders and Deficiencies
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|ClinicalTrials.gov Identifier: NCT01981785|
Recruitment Status : Unknown
Verified April 2017 by Oral Alpan, O & O Alpan LLC.
Recruitment status was: Active, not recruiting
First Posted : November 13, 2013
Last Update Posted : April 4, 2017
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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 or disease|
|Primary Immune Deficiencies Autoimmune Diseases Inflammatory Diseases Common Variable Immune Deficiencies Hypogammaglobulinemia|
|Study Type :||Observational|
|Actual Enrollment :||343 participants|
|Official Title:||Investigation of Molecular, Genetic and Cellular Mechanisms of Human Immune Disorders and Deficiencies|
|Study Start Date :||December 2012|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
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.
- 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.
- 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
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|Ages Eligible for Study:||1 Day and older (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
|Sampling Method:||Non-Probability Sample|
- 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.
- Risk factors for donating blood (such as anemia or blood clotting disorders)
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
|United States, Virginia|
|O&O Alpan LLC|
|Fairfax, Virginia, United States, 22030|
|Principal Investigator:||Oral Alpan, MD||O & O Alpan LLC|
|Responsible Party:||Oral Alpan, Principal Investigator, O & O Alpan LLC|
|Other Study ID Numbers:||
|First Posted:||November 13, 2013 Key Record Dates|
|Last Update Posted:||April 4, 2017|
|Last Verified:||April 2017|
Primary immune deficiencies
Common variable immune deficiencies
Primary Immunodeficiency Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Common Variable Immunodeficiency
Genetic Diseases, Inborn
Blood Protein Disorders