BioGene Bank Cohort Study for Approved Research Requests

The BioGene Bank Cohort Study is a Collection of Human Blood Samples (DNA and Plasma) Along With De-identified (Coded) Health Information, Questionnaire Responses on Environment and History of Family Disease to be Used for Research

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02550171

Acronym

BGB

Enrollment

7056

Registered

2015-09-15

Start date

2009-03-31

Completion date

2014-08-31

Last updated

2016-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Disease, Healthy

Keywords

Biobank, Genetics, DNA, Cohort, normal control

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.

Detailed description

The purpose of the BioGene Bank Cohort is to collect blood and store DNA from blood, along with health information to study how genetic variation in the population is associated with particular diseases, treatments and medical outcomes. Investigators may study the entire range of diseases and medical problems that exist within the NSLIJHS, including medical, surgical, psychiatric, pediatric and obstetric conditions. The specimens and medical information will be kept at a central Biorepository. This research study does not involve any treatment and individual research results are not provided.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
Time from symptoms to diagnosis of autoimmune diseases	10 years	Documentation of symptoms to diagnosis of autoimmune disease(s)

Secondary

Measure	Time frame	Description
Chart Review of Participants who are diagnosed with autoimmune disease	average of 10 years	Review of electronic health records with genetic data to possibly predict development of autoimmune disease

Countries

United States

Outcome results