“I am MURDOCK."
Gallery: MURDOCK Study [3 Images] Click any image to expand.
By: Kimberly Cassell
These three words are indicative of the significance local residents have with regard to the MURDOCK Study. Those that enroll get paid to provide blood and urine samples, medical history, body measurements and blood pressure. More important than the compensation is the database created from this information.
MURDOCK stands for Measurement to Understand the Reclassification of Disease of Cabarrus/Kannapolis. “In March 2007, Dr. Rob Califf, a world-renowned leader in cardiology and clinical research, led a visionary team at the Duke Translational Medicine Institute (DTMI) in the proposal of the MURDOCK Study,” Emily Ford, MURDOCK Study communications specialist, says.
That same year, David H. Murdock, founder of the North Carolina Research Campus (NCRC), donated $35 million to get the study underway; it has continued to be managed by Duke.
In those preliminary months before local residents were solicited, it was decided what diseases would be focused on within the study. Called Horizon 1, cardiovascular disease, obesity, liver disease and osteoarthritis were chosen using specimens from prior donors through Duke.
“The researchers working on these projects analyzed samples in an attempt to identify biomarkers and molecular signatures critical to the reclassification of disease. These efforts resulted in more than 20 publications, abstracts and presentations within a short time, prompting recognition and new funding for the MURDOCK Study. The success of these studies demonstrated that the reclassification of disease through biomarker analysis is both achievable and clinically significant,” according to murdock-study.com.
But, what are biomarkers and molecular signatures? On a basic level, body temperature is a biomarker for fever while cholesterol is a biomarker and risk indicator for heart disease. And Biomed Central defines molecular signatures as “sets of genes, proteins, genetic variants or other variables that can be used as markers for a particular phenotype (a person’s physical characteristics/health).”
Now with more money, the MURDOCK Study could move forward and approach the local community. In 2009, Horizon 1.5 saw the first study participants sign up. Their names were put into a community registry, and their medical samples and history into a biobank. This phase is open-ended, continuing to enlist participants at mass enrollments held at various locations in our area.
“More than 11,600 people have enrolled in the MURDOCK Study so far, making it one of the largest clinical research projects of its kind,” Ford explains. “Any adult who lives in our 20-zip code recruitment area can enroll. The recruitment area includes Cabarrus County, Kannapolis, China Grove, Landis and small portions of Rowan, Stanly and Mecklenburg counties.”
What Duke University researchers hope to accomplish is fine-tuning diagnoses and treatment of targeted diseases based on enrollees’ health information and medical samples. This is referred to as reclassifying disease. Why is one cancer different from other cancers; why does one diabetic respond differently to a particular treatment than another diabetic. Reclassifying disease is really another way to say precision medicine.
Ford walks us through the steps involved for a participant on enrollment day:
• Enrollment begins when a participant calls 704-250-5861, sends an email to firstname.lastname@example.org or clicks “enroll now” on our website at www.murdock-study.org.
• A Duke employee will contact the participant to schedule a 30-minute enrollment visit at one of our convenient enrollment sites, located in healthcare facilities throughout our 20-zip code recruitment area.
• When the participant arrives, a Duke University clinical research coordinator or clinical trials assistant will go through the informed consent process with the participant, who will be asked to sign a consent form.
• The participant will be asked to complete a questionnaire including basic information and health history, as well as a list of medications.
• The Duke staff person will take the participant’s blood pressure and pulse, measure waist circumference and collect a one-time sample of blood and urine, about 3 tablespoons of each.
• The participant will be asked to complete an annual follow-up form every year around the anniversary of his or her enrollment to document changes in health or medication. The MURDOCK Study office sends this form, which takes about 10 minutes to complete, to all participants, who fill it out online or on paper.
• Participants may be contacted up to four times per year for other study opportunities. Many MURDOCK Study participants enroll in sub-studies – or cohorts – of the main study.
• Participants in the MURDOCK Study Community Registry and Biorepository are compensated with a $10 gift card. People who also join sub-studies receive additional compensation, which varies. MURDOCK Study participants who refer a friend or family member to the study, who then enrolls, are entered into a quarterly raffle for a $50 gift card. MURDOCK Study participants who complete their annual follow-up form are entered into a quarterly raffle for a prize of their choice valued at up to $150.”
Duke University currently has a full-time staff of 36. Twenty-eight are in Kannapolis and eight are in Durham, all concentrating on either the MURDOCK Study or Duke’s other population health research projects.
“Our full-time staff includes project leaders, clinical research coordinators, clinical trial assistants, data specialists,
data technicians, recruiters, marketing
and communications staff, informaticists and staff assistants,” Ford says. “Duke’s presence in Kannapolis will expand this summer into a 5,000-square-foot clinical space in the new NCRC Medical Plaza, where our clinical coordinators, recruiters and communications team will relocate. We will maintain our original office at 147 West Avenue in the NCRC Village as well, which will house the data management team.”
Ford goes on to explain that physicians and research scientists who work with the MURDOCK Study are called study investigators or principal investigators. “More than a dozen principal investigators have conducted research with MURDOCK Study samples and data to better understand diseases including osteoarthritis, obesity, liver disease, heart disease, severe acne and multiple sclerosis, as well as memory, cognitive health, male fertility and physical performance.
“The MURDOCK Study aims to understand disease at the molecular level, and investigators are working to identify linkages across major diseases in order to defeat some of today’s leading causes of illness and death. The MURDOCK Study team is evaluating a nutrition research proposal to integrate into its study portfolio and is very excited about the prospect of expanding its breadth to include understanding how nutrition affects health and disease,” she says.
While the study’s four initial diseases were identified in Horizon 1, “there are currently more than 20 proposals under development with investigators and potential collaborators for new research opportunities using the MURDOCK Study samples, data and infrastructure,” Ford says. “Possible studies include COPD, diabetes, obesity, chronic kidney disease, prostate cancer, atrial fibrillation, nutrition and smoking.”
Some exciting results have come out of the last seven years’ research. Ford explains:
• Regional and cultural differences influence the assessment of cognitive function, information that will be important in future wide-scale
research in memory loss and Alzheimer’s disease.
• Investigators identified a proteomic profile that predicts response for patients with hepatitis C virus. A commercially available lab test was created that could determine a patient’s profile. This means doctors can determine with a blood test whether their patients with hepatitis C will respond to interferon treatment, saving those who will not respond from suffering the side effects of the treatment.
• Dr. Simon Gregory and his collaborators identified the IL7R gene’s association with multiple sclerosis, forming the basis of ongoing study to understand the mechanism and signaling of the gene and opening up a new field of research into how the gene contributes to the development of MS.
• Also in multiple sclerosis research, MURDOCK Study investigators are discovering how small molecules in the blood – called metabolites – are related to the disease and how these profiles may be different between women and men with MS.
• Researchers identified new protein markers to diagnose knee osteoarthritis. They determined that fractal signature analysis (FSA) – a type of X-ray image analysis – can predict the progression of arthritis of the knee. The study was the first biomarker to show specificity for a particular joint site and has led to additional research studies.
• MURDOCK Study samples have been used as “controls” in a number of other studies, providing the crucial comparison necessary as part of many clinical research investigations. A control is a sample from a healthy individual used to compare variables such as age, sex, race and ethnicity. Controls allow researchers to gather relevant data quickly and easily. If the sample and control groups are properly designed, relatively few participants can help answer questions about much larger populations. That’s why the MURDOCK Study recruits healthy volunteers as well as people who have health problems. Both groups are extremely valuable for research purposes. Techniques like these enable researchers to gather accurate information, draw reliable conclusions, and understand diseases and treatments.
As of last January, Dr. Kristin Newby leads the MURDOCK Study as principal investigator; Dr. Califf is now deputy commissioner for Medical Products and Tobacco at the U.S. Food and Drug Administration. Instrumental in the design of the MURDOCK Study, Dr. Newby continues to work with many of the other original thought leaders, including Victoria Christian, chief operating officer for the Duke Translational Research Institute (DTRI).
Next on the horizon is the expansion of the study’s research internationally. With the MURDOCK Study’s data combined with data from around the world – and derived from different geographic and ethnic regions – new theories can be tested and old theories substantiated. Duke is presently partnering with institutions in Singapore, India and Shanghai.
With a goal of 50,000 enrollees, “the MURDOCK Study will help bring to fruition the promise of ‘precision medicine,’ the concept that doctors will know how to use a person’s genetic, clinical, social and environmental characteristics to tailor prevention and treatment strategies to that patient’s unique characteristics and needs,” its website says.
“The MURDOCK Study has matured to the point that analyses are being initiated with the clinical data and biological samples that have been collected,” Ford adds. “Many research grants have been submitted to use the MURDOCK Study resources – the clinical information and samples contributed by the participants – to better understand such common diseases as high blood pressure, memory loss and Alzheimer’s disease, physical function and aging, coronary disease, kidney disease and cancer.
“Study investigators are beginning to generate and analyze data from more than 400,000 biological samples stored in Kannapolis, as well as from the health information provided each year by participants in their annual follow-up form. In collaboration with the Dole Nutrition Research Institute, the David H. Murdock Research Institute and other partners at the North Carolina Research Campus, the MURDOCK Study during the next decade will increase its focus on studies of nutrition and the effects on health and illness of food and exercise.”
Again, follow-up after the initial enrollment is very important. Informing MURDOCK representatives on an annual basis about any health changes is vital.
Says Ford, “While many of our volunteers originally hail from Cabarrus County and the surrounding area, we have participants from all over the world who live here and enroll because they know the impact MURDOCK Study research could potentially have across the globe.”