In August, tennis star Venus Williams withdrew from the U.S. Open, saying she was suffering from fatigue and other symptoms related to Sjögren's syndrome, an autoimmune disorder that results in the loss of the ability to produce saliva and tears. Her announcement focused public attention on this malady, which affects nearly 4 million Americans.
While women are nine times more likely than men to develop Sjögren's, the disorder affects virtually every racial and ethnic group. Most patients develop symptoms after age 40, including dry eyes, dry mouth and often joint pain and chronic fatigue. And because of their paucity of saliva and the antibacterial chemicals it contains, patients may also develop tooth decay and cavities.
While much is known about the symptoms of Sjögren's, the disease is complex and poorly understood, and in some cases, it can take more than six years to be diagnosed.
The UCLA School of Dentistry has now received a $2.8 million grant from the National Institute of Dental and Craniofacial Research, part of the National Institutes of Health, to support a multi-center clinical trial of a diagnostic test that uses patients' saliva to determine whether they have Sjögren's syndrome. This simple, non-invasive test will permit a diagnosis within minutes, rather than the weeks currently required when using blood or other tissue samples.
The project will be led by Dr. David Wong, associate dean for research and the Felix and Mildred Yip Endowed Professor in Dentistry at the UCLA School of Dentistry. For Dr. Wong and his colleagues, who have been conducting research on using saliva as a diagnostic tool for biomarkers of oral cancer, early-stage pancreatic cancer and other maladies for several years, this is an important step in moving from the research realm to actual clinical trials and, eventually, to use by medical and dental practitioners.
"This clinical trial will make it possible to validate the effectiveness of salivary diagnosis and move us a step closer to eventual FDA approval and clinical product development," Wong said. "The establishment of scientifically credible biomarkers for this chronic autoimmune disease that are not invasive, painful or embarrassing is our goal."
Clinical trials will be conducted at three major rheumatology centers, at University Medical Center Groningen in the Netherlands, the University of Minnesota and the Oklahoma Medical Research Foundation. Centers will enroll patients exhibiting sicca symptoms of dry eye and dry mouth and will perform the saliva biomarker assay based on a panel of highly discriminatory salivary biomarkers developed at UCLA. Researchers will benchmark the outcome with the current clinical practice of six clinical tests, including serology and a lip biopsy, to diagnose Sjögren's syndrome (AECC 2002 criteria).
"The UCLA School of Dentistry is very proud to be at the forefront of this international effort to advance the field of saliva diagnostics from the research laboratory to clinical trials," said No-Hee Park, dean of the UCLA School of Dentistry. "The prospect of early detection of Sjögren's syndrome, and possibly other serious illnesses, in the future through this methodology is truly exciting."
The UCLA School of Dentistry is dedicated to improving the oral health of the people of California, the nation and the world through its teaching, research, patient care and public service initiatives. The school provides education and training programs that develop leaders in dental education, research, the profession and the community; conducts research programs that generate new knowledge, promote oral health and investigate the cause, prevention, diagnosis and treatment of oral disease in an individualized disease-prevention and management model; and delivers patient-centered oral health care to the community and the state.