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Boasting 100K Enrollees, VA Genetic Research Program Moving Steadily Toward Million Vet Goal

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The Department of Veterans Affairs has enrolled its 100,000th volunteer for the Million Veteran Program, a large-scale, longitudinal research effort to uncover genes associated with diseases and advance personalized treatment strategies.

The program, launched last year (PGx Reporter 5/11/2011), aims to enroll 1 million veteran volunteers over the next six years. With informed consent from participants, VA researchers will collect biological samples for genetic analysis and give volunteers questionnaires to gather data on their lifestyle, health, and military exposure. Researchers will then investigate the relationship between veterans' genes, their environment, and their health.

According to Timothy O'Leary, director of clinical science research and development at the Veterans Health Administration, study investigators haven't yet begun genetic analysis of volunteers, but over time, they plan to use a variety of approaches, including chip-based SNP and copy number variation analysis, exome sequencing, and whole-genome sequencing.

"A contracting process for whole-genome sequencing is underway; our initial decisions on the approach to whole-genome sequencing will be made as a part of that process," O'Leary told PGx Reporter, adding that "some genotyping and analysis" of study participants is slated to occur in the current fiscal year ending Sept. 30, 2013.

Approximately 20 percent of veterans that the VA has contacted about participating in the study have expressed an interest in being a part of the project. "A slightly smaller number" of veterans say they'd rather not participate, according to O'Leary.

In addition to responses to mail or phone requests, the VA is also seeing volunteers walk into study sites to enroll in the project. Even some whom the VA hasn't contacted about the project by mail have on their own accord volunteered for the study.

Approximately half of the current volunteers are in the 60- to 69-year-old age bracket. "[This] is an age range in which many individuals will see an increase in their own healthcare utilization," O'Leary said. "I suspect that those individuals who are most engaged with the healthcare system are also those for whom the benefits of this effort are most obvious."

Blood samples collected as part of the Million Veteran Program are being stored in a biobank in Boston and are labeled with a barcode to ensure participants' privacy. Although veterans will be able to access their genomic data and research findings, this information will not be included in their electronic health records. As a further privacy measure, VA researchers with access to the study data are blinded to the identities of the volunteers.

O'Leary has previously highlighted a number of studies the study investigators hope to pursue after collecting the genetic and phenotypic data from volunteers. For example, the first study, called CSP 572, will study the genetic underpinnings of bipolar disease and schizophrenia. Patients in the Million Veteran Program will be the reference cohort for the study. Researchers are hoping to enroll 9,000 individuals with bipolar disorder, another 9,000 with schizophrenia, and 20,000 participants in the reference population.

"Enrollment in this study, which requires the collection of substantial additional data, is well underway," O'Leary said, noting that researchers have enrolled "substantially more volunteers than required" for the reference cohort.

Additionally, pilot studies looking at the genetics underlying post-traumatic stress disorder "demonstrated the need to refine our plans for enrolling and studying the genetics of this condition," he noted. O'Leary did not elaborate on the specific changes the researchers might make to this trial.

The VA is conducting meetings to discuss rapid advancements in genetic technologies that could impact the course of these studies. Researchers are also developing informatics resources that will be needed to perform the different types of studies the VA wants to conduct under the Million Veteran Program.

There are currently 40 VA medical centers participating in the program, and the project aims to expand to other sites in the near future. "We hope to enroll a similar or larger number of veterans in the coming year, and are working to increase the number of ways in which veterans can become part of this important partnership," O'Leary said.

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