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Baseline Genomic Data Study Aims to Enroll Children

Analysis  |  By  
   June 07, 2016

As Google-spawned Baseline Study enrollment begins, it seeks to enroll a healthy population, a high-risk population, and a population of the already-sick. A Stanford executive hopes to also enroll a pediatric cohort.

As Verily Life Sciences (formerly Google Life Sciences) begins to enroll patients in its Baseline Study this month, one executive at study partner Stanford Healthcare expects to expand the study to children.

In an interview, Dennis Lund MD, chief medical officer of Lucile Packard Children's Hospital Stanford, describes the Baseline Study as "the Framingham Heart Study of the modern world."

A joint undertaking of Verily, Stanford Medicine, and Duke University School of Medicine, the longitudinal cohort study plans to enroll 10,000 patients, Lund says.

Where the Framingham study looked for risk factors for development of heart disease, the Baseline Study will track genomic data based on blood, urine, and saliva tests, along with full genomic analysis, he says.

Jessica Mega, MD, chief medical officer at Verily, described the study's objectives in an interview last December: "We'll try to understand the fundamental building blocks—the systems biology for what it means to be free of overt disease, what we call "healthy." Then we'll follow people to try to capture the early signs of that transition, with the goal of trying to prevent disease as we go forward."

"We're looking at patients' medical histories and family histories, looking at their symptoms and phenotypic data, and also data that can be derived from wearables," Lund says.

One segment of the study will be a healthy population, and a second segment will be a population that has a high risk for heart disease or cancer, based on that population's genomic information.

A third segment will be a group which already has had heart disease or cancer. The study will look for potential for this population to experience a relapse, Lund says.

Enrolling Children

"Unfortunately for the pediatric world, there are no children intended to be enrolled in the study right at the beginning, but at Packard we're very, very interested in expanding this kind of research project to children, so hopefully we can do that," he says.

Current funding for the Baseline Study is $5 million, and Lund does not know exactly how long it will take to enroll all 10,000 participants.

"I think part of the reason why there are no children in the study is obviously there are lots of kind of legal implications to getting permission to study children," he says.

"They want to roll this thing out first, get it set up, before they take on that added complexity."

Some of the wearables in the study will be designed by Verily, but Lucile Packard may eventually provide some of its own.

"We are actively working with Apple's HealthKit product," Lund says. "We've developed a diabetes monitoring kit for kids who have type 1 diabetes. It actively and continuously transmits their glucose levels into their Epic records."

Another Stanford-developed wearable is a patch worn by kids or adults with irregular heartbeats. "The most common one we worry about in kids is something called Long QT Syndrome, which is associated with sudden death," Lund says.

"We can measure it with the monitor, and there are certain medications that affect it. So we know we want to stay away from those medications.

"All of these things often have some kind of longitudinal cohort study associated with them, analogous to the Baseline Study. Not quite as comprehensive as Baseline Study, because that's really kind of a moonshot kind of a project."

The wearables are a product of the Stanford Byers Center for Biodesign, where physicians and engineering graduate students, geographically situated as they are in the midst of Silicon Valley, are paired up to work on interesting clinical challenges, Lund says.

"The goal is actually to then develop a solution, license it, and commercialize it," he says.

Stanford Children's is in the midst of an expansion, due for completion in September 2017, which will free it from being dependent on the adjacent adult Stanford Hospital for resources, Lund says.

"Also, we'll upgrade our technology to be more state-of-the-art," he says.

"For example, we have one of the biggest and best heart surgery programs here, but we don't have a hybrid OR. Well, the state of the art now in cardiac surgery for children is to do things combined… so you've got to have… not only the operating room capability, but the radiology capability, all in one room."

Scott Mace is the former senior technology editor for HealthLeaders Media. He is now the senior editor, custom content at H3.Group.

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