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Home > ARRA Stories > Drs. Katrina Goddard and Evelyn Whitlock: Comparing Gene Tests for Colon Cancer
Drs. Katrina Goddard and Evelyn Whitlock: Comparing Gene Tests for Colon Cancer

By Alison Davis

April 15, 2010

Photo of Katrina Goddard

Dr. Katrina Goddard

Katrina A.B. Goddard, Ph.D., Senior Investigator, and Evelyn P. Whitlock, M.D., Director, Evidence-Based Medicine, Kaiser Permanente Center for Health Research, Portland, Oregon

Coming to the fore are a whole new range of genetic tests to predict disease risk and drug response. What effect will the tests have, and will they change how doctors prescribe drugs and try to influence patient behavior? Scientists Dr. Katrina Goddard and Dr. Evelyn Whitlock are trying to find out.

The Problem: Although many think of gene tests as new technology, gene-based testing has been around for years. Examples include newborn screening for inherited diseases, carrier testing for sickle-cell anemia and other diseases, and more recently, preimplantation genetic testing of embryos.

A wealth of information has emerged from the Human Genome Project, The Cancer Genome Atlas, and other large-scale projects to generate DNA readouts from healthy and diseased cells. Researchers are jumping on rapid advances in technology to harness this information into medical products, such as diagnostic tests and gene-based drugs that enable personalized treatment for a range of diseases.

To date, cancer appears to be the furthest along, likely because cancer is thought to be mostly a disease of DNA. Gene tests are currently available to identify some types of inherited breast cancer, blood cancers like leukemia and lymphoma, and others.

For colon cancer, some gene tests have gone from the laboratory to the doctor's office in record time, says Dr. Goddard, while others have taken much longer to become adopted in practice. Drs. Goddard and Whitlock are teaming up with Kaiser Permanente's Dr. Larry Kushi and colleagues across the HMO Research Network to study the impact on health and clinical practice of two gene tests in colon cancer.

The two tests provide different kinds of information, Dr. Goddard explains. One test, abbreviated KRAS, predicts response to colon cancer treatment, while the other, called Lynch Syndrome, identifies a rare, inherited form of colon cancer that is treatable if caught early.

Photo of Evelyn Whitlock

Dr. Evelyn Whitlock

Finding a Solution: This multisite set of research projects will compare survival outcomes in patients who received the KRAS test with those who did not. It will also evaluate how KRAS tests are used in practice across seven health plans and will examine the cost-effectiveness of both KRAS and Lynch Syndrome testing.

This project allows Dr. Goddard and Dr. Whitlock to test-drive a new approach that blends evidence generation — the accumulation and interpretation of data in a single study — with evidence synthesis — assessing the combined meaning of multiple studies — all within a single research project. Typically, the two research processes are separated in time and in space, and sometimes they don't connect at all, says Dr. Goddard.

"If you know how data may be used in evidence synthesis, policy, and practice, you can better design projects with those goals in mind," she continues.

"We are already learning that both types of researchers benefit from putting these two research activities together," says Dr. Whitlock. "We will find out whether the two gene tests differ between labs and understand more about test-related harms."

In addition, the project should reveal perceptions of patients and doctors and should inform future research.

So how will the researchers anticipate using information from genetic testing? This "horizon scanning" is a work in progress, and scientists in this project will compare their results with methods used by others. Since technology-related research is moving too fast to simply wait for peer-reviewed publications, researchers will follow scientific presentations at meetings, scan online research databases, maintain contacts with libraries and manufacturers, and even monitor "softer" sources like news reports.

How This Funding Helps: The Recovery Act funding opportunity has been "transformational," say the researchers. Because of the short time frame, focusing on a well-developed set of research questions that will advance knowledge that is close to translation into practice and policy is paramount, says Dr. Whitlock.

"We are challenged and thrilled to have the chance to work together so closely," she adds.

After Two Years … According to Dr. Whitlock, this research will tell us how colon cancer genetic testing affects decision making and health outcomes. Along with a cost-effectiveness study, the project should inform the development of clinical guidelines for colon cancer diagnosis and treatment.

Another outcome will be an effective method for anticipating research, and this approach can be adopted by other researchers and health officials. Related state-of-the-science products will provide concise summaries of knowledge generated from multiple sources and identified as such.

"This is a tremendous undertaking," says Dr. Goddard. "We are excited to have a chance to influence policy and at the same time help patients and providers."

Recovery Act Investment:

"Comparative Effectiveness in Genomic and Personalized Medicine for Colon Cancer," $1,999,998 for FY 2009. Funded by the Office of the Director, NIH.

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Research/Disease Category

  • Cancer
  • Clinical Research
  • Colo-Rectal Cancer
  • Comparative Effectiveness Research
  • Cost Effectiveness Research
  • Digestive Diseases
  • Health Services
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