Genes and Phenotype (GAP) A National Resource for Genotype-Phenotype Studies of Immunological and Inflammatory Pathways (GAP)
Primary Purpose
Immune System Diseases
Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Immune System Diseases
Eligibility 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
Sites / Locations
- The Feinstein Institute for Medical Research
Arms of the Study
Arm 1
Arm Type
Arm Label
Healthy Control Group
Arm Description
Outcomes
Primary Outcome Measures
Number of healthy participants enrolled
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
Secondary Outcome Measures
Full Information
NCT ID
NCT01161056
First Posted
July 9, 2010
Last Updated
September 9, 2015
Sponsor
Northwell Health
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), University of Alabama at Birmingham
1. Study Identification
Unique Protocol Identification Number
NCT01161056
Brief Title
Genes and Phenotype (GAP) A National Resource for Genotype-Phenotype Studies of Immunological and Inflammatory Pathways
Acronym
GAP
Official Title
Genes and Phenotype (GAP) A National Resource for Genotype-Phenotype Studies of Immunological and Inflammatory Pathways
Study Type
Observational
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwell Health
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), University of Alabama at Birmingham
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immune System Diseases
7. Study Design
Enrollment
5000 (Actual)
Biospecimen Retention
Samples With DNA
Biospecimen Description
Blood sample will be processed to isolate DNA and peripheral blood mononuclear cells, which will be stored in our Biorepository.
8. Arms, Groups, and Interventions
Arm Title
Healthy Control Group
Primary Outcome Measure Information:
Title
Number of healthy participants enrolled
Description
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
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Study Population Description
Healthy Controls
Sampling Method
Non-Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Gregersen, MD
Organizational Affiliation
The Feinstein Institute for Medical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Feinstein Institute for Medical Research
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Genes and Phenotype (GAP) A National Resource for Genotype-Phenotype Studies of Immunological and Inflammatory Pathways
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