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NCT02550171 Clinical Trial

BioGene Bank Cohort Study for Approved Research Requests

Healthy Clinical Trial

— BGB  

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02550171
Other study ID # 08-094
Secondary ID Other
Status Completed
Phase N/A
First received October 9, 2013
Last updated September 16, 2016
Start date March 2009
Est. completion date August 2014

Study information
Verified date September 2016
Source Northwell Health
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 7056
Est. completion date August 2014
Est. primary completion date August 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 1 Year and older
Eligibility 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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States The Feinstein Institute for Medical Research Manhasset New York

Sponsors (1)
Lead Sponsor Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Time from symptoms to diagnosis of autoimmune diseases Documentation of symptoms to diagnosis of autoimmune disease(s) 10 years No
Secondary Chart Review of Participants who are diagnosed with autoimmune disease Review of electronic health records with genetic data to possibly predict development of autoimmune disease average of 10 years No
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