Genes and Phenotype (GAP) A National Resource for Genotyp... | NCT01161056

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

NCT01161056

Sponsor

Northwell Health

Status

Completed

Last Update Posted

Sep 10, 2015Estimated

Enrollment

5,000Actual

Phase

Not provided

Conditions

Immune System Diseases

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
1RC2AR059092-01	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Sep 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2009

Primary Completion Date

Apr 2015Actual

Completion Date

Apr 2015Actual

First Submitted Date

Jul 9, 2010

First Submission Date that Met QC Criteria

Jul 12, 2010

First Posted Date

Jul 13, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 9, 2015

Last Update Posted Date

Sep 10, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Peter Gregersen, Center Head, Northwell HealthPrincipal Investigator

Lead Sponsor

Northwell HealthOTHER

Collaborators

Name	Class
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	NIH
University of Alabama at Birmingham	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

Retention

Enrollment

5,000Actual

Label	Type	Description	Intervention Names
Healthy Control Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	5 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Healthy Controls

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Peter Gregersen, MD	Northwell Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Feinstein Institute for Medical Research		Manhasset	New York	11030	United States

Condition Browse Module

MeSH Terms

ID	Term
D007154	Immune System Diseases

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided