The University of Florida has secured modest funding to initiate a “BioMarker Substudy” of INVEST called "Heart Disease Outcomes: Impact of Genetics and Pharmacogenetics”. We are inviting you to participate in this exciting and important substudy. 

The Human Genome Project recently completed its analysis of the entire human genome.  Many believe that this accomplishment has ushered us into the “genomics era”, and it is predicted by many that genomics will cause a revolution in medicine.  Lay, as well as scientific literature is now filled with information about important new genetic findings and how it will change medicine in the future.  It is believed that use of genetic information will transform biomedicine in many ways, including identification of genetic determinants of disease and disease progression, prediction of drug response and/or toxicity, and discovery of new therapeutic agents.

Our objective with the Biomarker Substudy is to create a genetic database within the INVEST population that can be coupled with the clinical information being generated.  This will allow us to test hypotheses of relationships between genetic polymorphisms (interpatient variability in the genetic code) and cardiovascular disease, cardiovascular disease outcomes and drug response.  We believe the INVEST Biomarker Substudy has the potential to generate very important information for the new genomics era.

Participation in this Biomarker Substudy is simple for you/your staff and the patient.  The genetic sample we wish to collect is a buccal cell sample; no blood collection is required.  To participate you must simply:

• obtain informed consent from the INVEST study participant
• use the study kit provided, and
• have subject swish Scope^® mouthwash for one minute and then spit into a container
• complete all information on lable, affix  label to the mouthwash sample
• store the mouthwash sample, with or without refrigeration, until shipment
• ship the sample to the University of Florida via prepaid overnight courier

We have taken extensive efforts to insure the protection of individual patients with respect to patient confidentiality and the genetic results.  First, we will not be testing for any genetic traits that are well documented to be associated with disease (e.g. the breast cancer gene).  Second, no genetic information will be provided to the patient or to you, or placed in the patient’s medical record.  Third, those investigators involved in the genetic analysis will have no information about patient identity, and no access to the INVEST database which might contain any information regarding patient identity.  INVEST study participants should also understand that their participation in this substudy is completely voluntary and would not impact in any way their participation in the main study.

Identification and validation of genetic polymorphisms that are important determinants of disease, outcomes or drug response require large populations, such as the one enrolled in INVEST.  Thus, we hope you will join us in this important research effort that should add substantially to the overall impact of the INVEST study.

Please review the protocol for this very important study. Email kolbhr@ufl.edu or call us at 1-888-214-2168 for further information.