NCT02550171

Brief Summary

The BioGene bank: Is a centralized collection of human blood samples along with de-identified (coded) health information, environmental factors, family disease histories and information from DNA. Limited to the NSLIJHS catchment area.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
7,056

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2009

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

October 9, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

September 15, 2015

Completed
Last Updated

September 19, 2016

Status Verified

September 1, 2016

Enrollment Period

5.4 years

First QC Date

October 9, 2013

Last Update Submit

September 16, 2016

Conditions

HealthyChronic Disease

Keywords

BiobankGeneticsDNACohortnormal control

Outcome Measures

Primary Outcomes (1)

  • Time from symptoms to diagnosis of autoimmune diseases

    Documentation of symptoms to diagnosis of autoimmune disease(s)

    10 years

Secondary Outcomes (1)

  • Chart Review of Participants who are diagnosed with autoimmune disease

    average of 10 years

Eligibility Criteria

Age1 Year+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Anyone receiving care at the NS LIJ Health System and family members.

You may qualify if:

  • Anyone receiving care at the NS LIJ Health System would be eligible to join the BioGene Bank Cohort.
  • Participants' family members who may or may not have medical records at NSLIJHS.

You may not qualify if:

  • Patients unable to give consent because they are decisionally impaired or have a language barrier that cannot be overcome.
  • Patients unable to provide a blood sample because it would adversely affect their health or who refuse to provide blood sample or share future discarded biological samples.
  • Patients \<10kg in weight

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Feinstein Institute for Medical Research

Manhasset, New York, 11030, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

DNA

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Peter K Gregersen, MD

    Northwell Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Center Head: Robert S. Boas Center for Genomics and Human Genetics

Study Record Dates

First Submitted

October 9, 2013

First Posted

September 15, 2015

Study Start

March 1, 2009

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

September 19, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)