BioGene Bank Cohort Study for Approved Research Requests

Completed

• Conditions: Healthy; Chronic Disease

• Registration Number: NCT02550171
• Lead Sponsor: Northwell Health

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.

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2013-10-09
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Study First Submitted QC: 2015-09-14
• Study First Posted: 2015-09-15
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-16
• Last Update Posted: 2016-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7056

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time from symptoms to diagnosis of autoimmune diseases	10 years	Documentation of symptoms to diagnosis of autoimmune disease(s)

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

The Feinstein Institute for Medical Research; 🇺🇸 Manhasset, New York, United States