“My hope is that all my years of study and training ultimately have an effect on patients’ lives. In the end, new discoveries are really the stepping stones to helping patients.” – Steven J. Skates, PhD
Developing new statistical methods for early detection of cancer and evaluating their impact through multiple large clinical screening trials is not easy. Just ask Dr. Steven Skates. Building upon his formidable biostatistics expertise, Dr. Skates has spent decades designing early detection methods which accurately diagnose early-stage ovarian cancer when it may be more treatable and curable with existing therapies.
Currently when a woman is suspected of ovarian cancer, she is often screened for a blood biomarker, called CA-125. If the blood test result exceeds the threshold level of 35, she is evaluated further for ovarian cancer. Because ovarian cancer is relatively infrequent, it is crucial that this initial blood test is very accurate. If the initial screening provides too many false positive results, they can overwhelm the true positive cases.
Dr. Skates has a better way to screen women for ovarian cancer that personalizes the blood test to each individual.
By establishing an individual’s baseline for the biomarker and allowing for the natural biomarker fluctuations that occur over time, Dr. Skates’ method increases the accuracy of early detection screening for ovarian cancer. In this method, a woman’s blood test results are monitored over time and her risk of ovarian cancer is estimated after each test result. When this risk, based on her personal CA-125 history, is increased, she is then referred for further evaluation.
This method is more accurate than the current approach because it reduces the number of false positives in women who have elevated but stable CA-125 levels. In addition, it increases the chance of detecting the true positives early by identifying these women based on their own baseline levels of CA-125.
“It sounds easy,” says Dr. Skates. “But it has taken me twenty years to develop and test this sensitive and systematic algorithm, first in a pilot screening trial of 14,000 normal risk women over five years, then in a much larger 15 year trial.” In 2015, the largest clinical screening trial to implement this method, comprised of 200,000 women, half randomized to screening and half receiving standard care, will be ready for Dr. Skates and his team to begin analyzing the results.
“We’ll get a chance to see if we’ve been successful in reducing ovarian cancer mortality,” says Dr. Skates, Associate Professor in the Department of Medicine at the Massachusetts General Hospital Cancer Center and Harvard Medical School.
Over the past five years, Dr. Skates and his colleagues have also been leveraging the blood samples from their clinical trial participants to identify new ovarian cancer biomarkers that complement the biomarkers that are currently available.
With such a rich background in the early detection of cancer, Dr. Skates was excited to join LUNGevity’s Scientific Advisory Board and turn his expertise towards lung cancer.
“Colleagues at Harvard have died from lung cancer. It’s one of the biggest killers,” says Dr. Skates. “And the lung cancer community needs a blood test that’s inexpensive and accurate. It would be a great contribution the field.”
That is exactly where Dr. Skates excels. His areas of expertise: identifying new biomarkers, designing early detection methods and implementing them in screening studies are well-positioned to help LUNGevity and the lung cancer community as they search for screening methods and useful biomarkers.
Overall, whether Dr. Skates is reducing mortality of lung cancer patients or ovarian cancer patients, his motivation is the same. “My hope is that all my years of study and training ultimately have an effect on patients’ lives. In the end, new discoveries are really the stepping stones to helping patients.”