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Genes and Phenotype (GAP) A National Resource for Genotype-Phenotype Studies of Immunological and Inflammatory Pathways (GAP)

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ClinicalTrials.gov Identifier: NCT01161056
Recruitment Status : Completed
First Posted : July 13, 2010
Last Update Posted : September 10, 2015
Sponsor:
Collaborators:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
University of Alabama at Birmingham
Information provided by (Responsible Party):
Peter Gregersen, Northwell Health

Brief Summary:
The purpose of this study is to enrol generally healthy adults, who are asked to provide a blood sample, to study how the immune system works.

Condition or disease
Immune System Diseases

Detailed Description:

The primary purpose of this research is to develop a better understanding of how the immune system works. By studying immune function in many people, we will be able to determine the range of normal variation.

The second purpose is to enroll people who are willing to serve as comparisons in future research studies into the Genotype and Phenotype Research Registry (GAP Registry).

Volunteers are asked to provide information on age, ethnicity and medical history. Volunteers are asked to provide a blood sample of up to 100cc and allow us to contact you about additional studies.


Study Type : Observational
Actual Enrollment : 5000 participants
Official Title: Genes and Phenotype (GAP) A National Resource for Genotype-Phenotype Studies of Immunological and Inflammatory Pathways
Study Start Date : May 2009
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
Healthy Control Group



Primary Outcome Measures :
  1. Number of healthy participants enrolled [ Time Frame: 5 years ]
    This is a registry to enroll healthy individuals who are interested in being contacted about research studies they can participate in as a healthy control


Biospecimen Retention:   Samples With DNA
Blood sample will be processed to isolate DNA and peripheral blood mononuclear cells, which will be stored in our Biorepository.


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy Controls
Criteria

Inclusion Criteria:

  • Over age 18
  • Generally healthy

Exclusion Criteria:

  • History of autoimmune disease
  • History of chronic immunodeficiency or chronic viral infections such as Epstein Barr virus, hepatitis or HIV
  • Currently undergoing treatment for cancer
  • Current treatment with immuno-suppressant drugs
  • Pregnancy

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): NCT01161056


Locations
United States, New York
The Feinstein Institute for Medical Research
Manhasset, New York, United States, 11030
Sponsors and Collaborators
Northwell Health
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
University of Alabama at Birmingham
Investigators
Principal Investigator: Peter Gregersen, MD The Feinstein Institute for Medical Research

Responsible Party: Peter Gregersen, Center Head, Northwell Health
ClinicalTrials.gov Identifier: NCT01161056     History of Changes
Other Study ID Numbers: 09-081A
1RC2AR059092-01 ( U.S. NIH Grant/Contract )
First Posted: July 13, 2010    Key Record Dates
Last Update Posted: September 10, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
Immune System Diseases