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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
Northwell Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an observational trial for Immune System Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

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
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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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