HealthyBGBNCT02550171
BioGene Bank Cohort Study for Approved Research Requests
An observational study of Healthy and Chronic Disease, run by Northwell Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 1 year and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy, Chronic Disease
- How many people
- 7,056 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Aug 2014
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Anyone receiving care at the NS LIJ Health System and family members.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Feinstein Institute for Medical Research
Manhasset, New York, 11030
About this study
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
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.
Read the 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.
- Conditions
- Healthy, Chronic Disease
- Keywords
- Biobank, Genetics, DNA, Cohort, normal control
- Medical subject headings
- Chronic Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from symptoms to diagnosis of autoimmune diseases
Documentation of symptoms to diagnosis of autoimmune disease(s)
Measured: 10 years
Secondary outcomes (1)
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
Measured: average of 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2015 (estimated)
- Study startMar 2009
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7,056 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Gregersen, Northwell Health
- Investigators
- Peter K Gregersen, MD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02550171
- Sponsor's protocol ID
- 08-094
- Other IDs
- Other
- Acronym
- BGB
- Status last verified
- Sep 2016
- First submitted
- 9 Oct 2013
- Last updated
- 19 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02550171
- Acronym / sponsor ID
- BGB / 08-094
- Conditions
- Healthy, Chronic Disease
- Keywords
- Biobank, Genetics, DNA, Cohort, normal control
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,056 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 15 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Anyone receiving care at the NS LIJ Health System and family members.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time from symptoms to diagnosis of autoimmune diseases
Time frame: 10 years
Documentation of symptoms to diagnosis of autoimmune disease(s)
1 secondary outcome
Chart Review of Participants who are diagnosed with autoimmune disease
Time frame: average of 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter K Gregersen, MD principal investigator
Northwell Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy and Chronic Disease, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from symptoms to diagnosis of autoimmune diseases (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2016.