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Completed

NCT Number: NCT02550171

BioGene Bank Cohort Study for Approved Research Requests

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.

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Key information

Conditions

Healthy Chronic Disease Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

1 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Feinstein Institute for Medical Research

Manhasset, New York, 11030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Time from symptoms to diagnosis of autoimmune diseases

    Time frame: 10 years

    Documentation of symptoms to diagnosis of autoimmune disease(s)

Secondary outcomes

  1. Chart Review of Participants who are diagnosed with autoimmune disease

    Time frame: average of 10 years

    Review of electronic health records with genetic data to possibly predict development of autoimmune disease

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Registry information

Official study 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

Acronym: BGB

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Sep 15, 2015
Registry last updated
Sep 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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