Ignite Creation Date:
2024-05-05 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 9:54 AM
Study NCT ID:
NCT00741416
Status:
UNKNOWN
Last Update Posted:
2011-07-01
First Post:
2008-08-25
Brief Title:
Biorepository Indiana Health Study
Sponsor:
Fairbanks Institute
Organization:
Fairbanks Institute
Study Overview
Official Title:
Collection and Storage of Human Biological Materials Blood Sample and Linked Phenotypic Information Health History for Research Purposes
Status:
UNKNOWN
Status Verified Date:
2011-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IHS
Brief Summary:
Blood samples and health information eg age at diagnosis test results are collected for the purposes of genetic research The blood samples are assigned a number and stored in a repository for safe keeping until they are needed for a research project Participants are persons who are healthy not having high blood pressure diabetes or high cholesterol levels or persons who have Coronary Artery Disease CAD and live in Indiana Participants complete a questionnaire at the time the blood sample is drawn and are contacted once a year to update their health history Researchers apply to the Fairbanks Institute for use of the blood samples and health information minus participant names and contact information Their research is required to be related to find genes or substances made by genes that may be involved in Coronary Artery Disease with the purpose of improving the investigators understanding of the illness potentially leading to the development of new diagnostic tools for identifying the illness new treatmentsor preventative measures This study will be repeated for other disorders like Diabetes and Cancer
Detailed Description:
Study Aim
The purpose of this study is to create an extensively annotated bio-repository platform for hypothesis-driven research that will lead to advancements in the diagnosis treatment and prevention of diseases common to the population of Indiana The first phase of this research platform will be created by collecting blood samples from two groups of individuals in the Central Indiana community one with documented evidence of coronary artery disease CAD and a second group of age gender and ethnicity matched individuals without clinical evidence of CAD Each individuals blood sample will be linked to their clinical demographic and epidemiological information gathered both retrospectively and prospectively This will be repeated with individuals who have Cancer Diabetes and potentially other illnesses
Recruitment
This initial study will include 750 individuals with CAD the CAD Group and 750 individuals who are age gender and ethnicity matched to the CAD Group but without presentation of clinical evidence of CAD the Control Group To reflect the growing representation of Hispanics in Central Indiana Hispanics will be overly recruited in both groups so that the study population accurately reflects the general population of Central Indiana
Follow-up
As this is a prospective longitudinal study follow-up of study subjects is intended to continue indefinitely unless of course at any time consent for further follow-up is withdrawn by the subject Follow-up will include continuing access to the subjects medical record as well as facilitating continued contact by telephone to pursue data concerning changes in the subjects health Subjects may be contacted by telephone mail or email every twelve months to ask if they wish to continue participation in the study
The collected dataset made up of the collected blood samples linked to clinical and epidemiological information collected retrospectively and prospectively will be used in medical research to find genes or gene products such as RNA or proteins that will help in understanding the causes of disease and will guide the development of new treatments
The purpose of this study is to create an extensively annotated bio-repository platform for hypothesis-driven research that will lead to advancements in the diagnosis treatment and prevention of diseases common to the population of Indiana The first phase of this research platform will be created by collecting blood samples from two groups of individuals in the Central Indiana community one with documented evidence of coronary artery disease CAD and a second group of age gender and ethnicity matched individuals without clinical evidence of CAD Each individuals blood sample will be linked to their clinical demographic and epidemiological information gathered both retrospectively and prospectively This will be repeated with individuals who have Cancer Diabetes and potentially other illnesses
Recruitment
This initial study will include 750 individuals with CAD the CAD Group and 750 individuals who are age gender and ethnicity matched to the CAD Group but without presentation of clinical evidence of CAD the Control Group To reflect the growing representation of Hispanics in Central Indiana Hispanics will be overly recruited in both groups so that the study population accurately reflects the general population of Central Indiana
Follow-up
As this is a prospective longitudinal study follow-up of study subjects is intended to continue indefinitely unless of course at any time consent for further follow-up is withdrawn by the subject Follow-up will include continuing access to the subjects medical record as well as facilitating continued contact by telephone to pursue data concerning changes in the subjects health Subjects may be contacted by telephone mail or email every twelve months to ask if they wish to continue participation in the study
The collected dataset made up of the collected blood samples linked to clinical and epidemiological information collected retrospectively and prospectively will be used in medical research to find genes or gene products such as RNA or proteins that will help in understanding the causes of disease and will guide the development of new treatments
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None