NCT01981785

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
343

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2013

Completed
6 months until next milestone

First Posted

Study publicly available on registry

November 13, 2013

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

April 4, 2017

Status Verified

April 1, 2017

Enrollment Period

6 years

First QC Date

May 6, 2013

Last Update Submit

April 3, 2017

Conditions

Primary Immune DeficienciesAutoimmune DiseasesInflammatory DiseasesCommon Variable Immune DeficienciesHypogammaglobulinemia

Keywords

Primary immune deficienciesAutoimmune diseasesInflammatory diseasesCommon variable immune deficienciesPrimary ImmunodeficienciesImmunoglobulinIgGIVIGRecurrent Infections

Outcome Measures

Primary Outcomes (1)

  • Genetic variants

    To elucidate genetic variants associated with various previously identified immune disorders to include but not limited to immune dysregulations, hypersensitivities, inflammatory conditions and deficiencies.

    10 years

Secondary Outcomes (1)

  • Pathogenesis

    10 years

Study Arms (2)

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.

Eligibility Criteria

Age1 Day+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • Risk factors for donating blood (such as anemia or blood clotting disorders)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

O&O Alpan LLC

Fairfax, Virginia, 22030, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Primary Immunodeficiency DiseasesAutoimmune DiseasesAgammaglobulinemiaReinfection

Condition Hierarchy (Ancestors)

Genetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesImmunologic Deficiency SyndromesImmune System DiseasesBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesRecurrenceDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Oral Alpan, MD

    O & O Alpan LLC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 6, 2013

First Posted

November 13, 2013

Study Start

December 1, 2012

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

April 4, 2017

Record last verified: 2017-04

Locations

US(1)