Epic front and center in proposed cancer study ? Colorado Cancer ...

Colon cancer research would combine cutting-edge genetics, behavioral analysis

By Todd Neff

If you?re visiting an unfamiliar city, it?s great to have a map. But as seasoned travelers know, maps are only a starting point. The shortest path isn?t always the fastest, construction muddies otherwise optimal routes, and traffic can lay waste to the best-laid plans. And sometimes, drivers ignore even the best maps anyway.

The Cancer Genome Atlas project makes maps, but of a different sort used in any city on the globe. Most recently, the National Institutes of Health-funded effort published a sort of cartography of the genetic origins of colorectal cancer. Among its findings: colon and rectal cancer are, genetically speaking, one and the same. The project also rooted out several of the cancer?s molecular pathways? the roads normal cells travel as they change into cancers. The story made the front page of the New York Times.

CU School of Medicine researchers, including Gail Eckhardt, hope to pick up where the Cancer Genome Atlas project left off. They want to see if an improved understanding of colon cancer?s genetic mechanisms can help patients improve their odds of survival.

Now, with Cancer Genome Atlas data in hand, a team of University of Colorado School of Medicine researchers aims to see how the National Institutes of Health project?s findings play out on the streets of late-stage colorectal cancer care. They propose to combine Cancer Genome Atlas findings with their own genetic analyses of patients? tumors, then harness the power of the Epic electronic medical record (EMR) to help physicians in clinics at University of Colorado Hospital and Poudre Valley Health System (PVHS) make care decisions based on the genetic traits of a given patient?s cancer.

?It?s really a great effort to move this into an operational setting, where we would use this recently published data to type our patients and figure out the feasibility of moving [effective therapies] into the clinic,? said Gail Eckhardt, MD, the University of Colorado Cancer Center?s chief of Medical Oncology. Eckhardt, a specialist in phase 1 clinical trials and part of the team that crafted the proposal, was a member of the Cancer Genome Atlas?s colorectal cancer working group.

That effort, called ?Integrating Molecular Profiling Into Colorectal Cancer Care,? was submitted on July 19 as a response to a National Human Genome Research Institute (NHGRI) request for proposals.

In addition to Eckhardt, the lead investigators include David Schwartz, MD, the CU Department of Medicine chairman and a genetics expert; Michael Kahn, MD, PhD, director of the Colorado Clinical and Translational Sciences Institute?s biomedical informatics program; and Tasha Fingerlin, PhD, a Colorado School of Public Health epidemiologist. The four-year study, if chosen, would launch in 2013.

The genes

The study would involve 150 patients, half at UCH, the other half at UCH?s University of Colorado Health partner PVHS. These would be late-stage colorectal cancer cases where traditional therapies at even the highest rungs of the experimentaltherapy ladder had failed ? leaving patients with little hope beyond speculative phase 1 clinical trials.

Schwartz?s lab would assess genetic characteristics of the patients? tumors, then compare the results to the new roadmap provided by the Cancer Genome Atlas. In cases where a UCH or PVHS patient?s cancer seems to rely on a pathway pinpointed by the Cancer
Genome Atlas, some clinicians would receive notes in Epic saying as much. Those physicians would have the option of adjusting care ? for example, by choosing an experimental therapy known to impede that malignant pathway ? based on the information provided. Whether and how physicians use the additional information is a key part of the study, Kahn said.

The hypothesis, he said, is that clinicians usually decide on experimental agents based on ?very little evidence.?

With the new data from the Cancer Genome Atlas, physicians may be able to group patients according to the molecular mechanisms behind their cancers, Eckhardt and colleagues hope.

In addition, Eckhardt said, with genetic characteristics of patient tumors in hand, the CU team can see if those tumors are molecularly similar to those in roughly 100 ?preclinical models? ? mice harboring human cancers. If there?s a match, researchers can test out experimental therapies on the mice, boosting the odds that the same drugs benefit patients with similar tumors. The work will feed into a key study goal of speeding treatments from the research realm to the bedside, for patients who need it.

Enter Epic

The EMR will be central to the study, Kahn said, and would come into play at several points in the effort.

An oncogene is a gene with the capability of causing cancer.

Epic will store the records of patients who have consented to participate in the study and trigger an alert looking for new patients who have consented to receive it. It will instruct the tissue bank to fetch a patient?s tumor specimen for profiling in Schwartz?s lab and will let members of Epic Database Administrator Lenny Larchick?s team know they need to do a clinical data extraction of the patient?s record, pulling roughly 20 bits of information to help clinicians make therapeutic decisions.

To ensure the study is randomized, Kahn said, Epic will generate two reports for each patient in the study. One will have the basic clinical data extracted from the patient?s record and how he or she responds to experimental therapies. The second will have that information, plus the results of the genetic profiling done in Schwartz?s lab. On a random basis, some physicians will receive that molecular data, and others won?t, Kahn said.

When the research team manually uploads one report or the other, Epic will send an email to the physician and the study coordinator announcing the report?s availability. As the study proceeds, Epic will track whether physicians opened these reports, how long it took to open them, and whether the added molecular data had any impact on the therapies they chose for patients.

The study combines leading-edge genetic research with what amounts to a behavioral investigation of how physicians in different environments act when armed with the fruits of leading-edge genetic research. For example, will UCH physicians in an academic medical center treat the added information differently than those in the community hospitals in Fort Collins? Research data could help answer that question.

?It?s extremely exciting,? Kahn said. ?It?s what we hope will be the framework for how molecular findings can be combined with clinical decision making at the point of care ? the first of many studies toward realizing the vision of true personalized medicine. The significant investment in electronic health record technology makes it doable.?

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This article was first published in the UCH Insider. To subscribe to the UCH Insider, send an email to uch-publications@uch.edu.

Source: http://www.coloradocancerblogs.org/news/epic-front-and-center-in-proposed-cancer-study

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