Research

Big Steps Toward Early Cancer Detection

Posted on Feb 18, 2020 in Affiliates, Expanding Access, Innovation, Quality, Research, Scroll Images

SACRAMENTO, Calif. – Cancer researchers worldwide seek new clues to aid early detection and better treatments for cancer. The future is now, however, as research to support the development of a blood test for the detection of multiple types of the disease is underway at Sutter.

cancer blood test

Last month, Sutter began inviting eligible patients into the PATHFINDER clinical study. Sponsored by GRAIL Inc., the PATHFINDER study will evaluate the diagnostic capabilities of an investigational, multi-cancer early detection blood test. Sutter also helped support the development of GRAIL’s early cancer detection test by participating in the ongoing STRIVE study, which closed to enrollment at Sutter in 2018.

The goal of the PATHFINDER study is to enroll patients across eight sites at Sutter, currently the only health system in California participating in the multicenter PATHFINDER study. Other sites across the U.S. include Intermountain Healthcare, with additional centers launching this year.

While blood tests to detect or monitor cancer progression are not new, existing cancer tests typically screen for one type of cancer (e.g., breast cancer) and must be used with other screening tools . The PATHFINDER study is assessing whether GRAIL’s blood test will help aid early detection for multiple types of cancer with a single blood draw before symptoms present. The study will evaluate the implementation of the investigational test into clinical practice, and marks the first time results will be returned to health care providers and communicated to study participants to help guide diagnosis.

If the investigational test detects a cancer signal, it is designed to identify where in the body the cancer arises from, to inform the appropriate diagnostic next steps confirming if cancer is present.

Charles McDonnell, M.D., FACR

“Insights from the PATHFINDER study may improve how we screen for cancers and expand the types of cancer for which we can screen. Sutter’s participation in this study could help pioneer breakthroughs in early detection that may help save lives around the world,” says Charles McDonnell, M.D., FACR, a Sutter radiologist in Sacramento and lead principal investigator for the study at Sutter.

Dr. McDonnell and Andrew Hudnut, M.D., a family medicine doctor in Elk Grove, saw the potential and importance of the STRIVE study. They were instrumental in securing Sutter as a site for PATHFINDER.

“We anticipate this trial may allow us to personalize cancer screening and may eventually enable earlier, safer care for those patients found to have cancer,” says Dr. Hudnut.

During the PATHFINDER study, blood samples will be collected from eligible Sutter patients who consent to participate in the study. Blood samples will be analyzed for small pieces of the tumor’s DNA (i.e., its genetic “code”). If a study participant is diagnosed with cancer, the participant will be counselled on the results of their blood test and followed during workup to diagnose their cancer. There will be 12 months of follow-up for all participants.

PATHFINDER AT-A-GLANCE:

  • Study participants who are diagnosed with cancer will have their study test results communicated to them by qualified, Sutter clinical research staff and PATHFINDER study physicians. Participants will also receive e-mails and newsletters with information about follow-up appointments and study milestones.
  • The PATHFINDER study is part of Sutter’s coordinated efforts to improve cancer research and treatment outcomes for patients. Sutter also participates in large, phase 1-3 national clinical studies sponsored by the National Cancer Institute (NCI) and collaborates with pharmaceutical companies on cancer research.

Early cancer detection may be part of the “holy grail” for cure. Find out how you can help! Learn more about PATHFINDER by contacting the study team at pathfinderstudy@sutterhealth.org or call 916-746-2161.

Find more clinical trials and research at Sutter.

To Prevent Stroke, Start with the Heart

Posted on Feb 13, 2020 in Affiliates, Cardiac, Carousel, Expanding Access, Innovation, Mills-Peninsula Health Services, Neuroscience, Quality, Research, Scroll Images, We're Awesome, Women's Services

BURLINGAME, Calif. – Does it sometimes feel like there are butterflies in your chest? Does your heart race or skip a beat? If it’s not your crush making your heart go pitter-pat, it could be a common heart condition called atrial fibrillation or AFib for short. This Valentine’s Day, take heart and consider seeing an expert if you are experiencing these symptoms. After all, AFib dramatically increases the odds of having a life-threatening stroke.

“Stroke occurs when arteries in the brain are either blocked by a blood clot or burst under high pressure,” said Ilana Spokoyny, M.D., neurologist who cares for patients at Sutter’s Mills-Peninsula Medical Center. “So when we talk about stroke prevention, it’s natural that we emphasize how to keep clots from forming or keep blood pressure regulated—and both start with the heart.”

Heart health and stroke prevention were the focus of a recent educational event, hosted by United Airlines, and led by Sutter Health. Attendees toured Northern California’s only Mobile Stroke Unit – a specialized ambulance that has the staff and equipment on-board to start stroke treatment while enroute to a hospital – and heard from the unit’s director, Dr. Spokoyny, about two common heart conditions that increase stroke risk.

Atrial fibrillation

AFib is caused when the upper part of your heart beats out of sync with the lower half. While not usually life-threatening by itself, AFib alters the normal function of the heart which leads to the formation of blood clots in the heart. Eventually these clots are pumped out of the heart and can travel to the brain where they causes a stroke.

According to Dr. Spokoyny, nearly one in every six strokes is the result of AFib, and these strokes are often more serious. “Not only are AFib patients nearly five times more likely to suffer a stroke than those without the condition, AFib-related strokes are nearly twice as fatal and twice as disabling as non-AFib-related strokes.”

“AFib may be asympomatic or symptoms show up intermittently, and because they come and go many people don’t take them seriously,” Dr. Spokoyny explained. “We need to spread the word that you shouldn’t ignore the butterfly feeling in your chest or dismiss the occasional fatigue or shortness of breath you experience.” When diagnosed, AFib is treatable with medication or medical procedures, including surgery, to reduce your risk of stroke.

High blood pressure

High blood pressure increases the strain on blood vessels transporting blood throughout your body. When blood is routinely pumped through arteries at a higher than optimal pressure, the arteries may become weakened or narrowed, creating conditions where they burst or clog more easily.

Dr. Spokoyny reminds patients that high blood pressure is the single most important risk factor for stroke. “About three out of four people who have a stroke for the first time have high blood pressure.” High blood pressure often presents along with atrial fibrillation. The good news is that blood pressure can be managed with lifestyle changes and medications.

Expertise in action

Not-for-profit Sutter Health encourages doctors to work across specialties to ensure that patients receive high quality, coordinated care. Sutter includes sixteen Primary Stroke Centers across its integrated network.

Helping Mind the Gap on Cardiovascular Diseases

Posted on Feb 7, 2020 in Alta Bates Summit Medical Center, California Pacific Medical Center, Cardiac, Expanding Access, Innovation, Quality, Research, Scroll Images, Sutter Medical Center of Santa Rosa, Sutter Medical Center, Sacramento, Sutter Medical Foundation, Sutter Roseville Medical Center

Heart valve imaging
Heart valve imaging

Lifesavers appear in big sizes and small. For patient Adam Livingstone, rescue was a dime-sized clip that restored his heart’s normal rhythm and size. For months, Livingstone had been experiencing shortness of breath, chest pain and fatigue. Diagnosed with mitral valve regurgitation, a minimally invasive procedure to repair the valve was performed at Sutter Medical Center, Sacramento—one of Sutter’s sites where researchers evaluate new devices for treating damaged or diseased heart valves.

The Heart’s Finely Orchestrated Blood Flow

Heart valves
Heart valves

Like a musical conductor, the heart oversees rhythm and flow, circulating blood to each of its chambers in a coordinated, unidirectional symphony.

THE MITRAL VALVE

Mitral regurgitation, the most common type of heart valve disorder, occurs when blood leaks backward through the mitral valve when the left ventricle closes.

Some patients undergo non-surgical heart valve repair with transcatheter mitral valve repair (TMVR) with MitraClip®.2 During the procedure, doctors thread a catheter into a large leg vein reaching the heart. Then a dime-sized clip clamps the improperly working valve, allowing it to close more tightly with less backward blood flow.

“Some research participants recover faster and resume normal activities within a week of the procedure, and may not require lifelong anticoagulant medications, repeat surgeries, or re-hospitalization,” says David Roberts, M.D., FACC, FSCAI, medical director of cardiovascular services at Sutter in the Valley Area.

A new clinical trial at Sutter called PASCAL CLASP IID/IIF will test the safety and effectiveness of TMVR with the PASCAL Transcatheter Valve Repair System® compared with MitraClip® in patients with mitral regurgitation.3

For patients with severe mitral regurgitation, Sutter’s CPMC seeks to enroll patients in a clinical trial called SM3, which assesses the safety and efficacy of the SAPIEN M3 System™.4

“In this study, we are evaluating a new type of mitral valve that may provide a minimally invasive alternative to surgery for high-risk patients with severe mitral valve disease,” says David Daniels, M.D., co-director of Sutter’s Structural Heart Program in the Bay Area, and principal investigator of the SM3 clinical trial at Sutter.

Some patients develop mitral valve disease when calcium deposits accumulate on the fibrous ring attached to the mitral valve leaflets. For these patients with mitral annular calcification (MAC), Sutter will begin offering enrollment in the Summit clinical trial, which will test the safety and effectiveness of the Tendyne™ transcatheter mitral valve.5

“Previous approaches to treat patients with MAC have mainly involved the off-label use of transcatheter aortic valves,” says Dr. Roberts. “But this strategy may lead to residual mitral regurgitation and the need for open-heart surgery. Sutter’s participation in Summit may lead to novel ways to care for this hard-to-treat subset of patients.”

THE TRICUSPID AND AORTIC VALVES

Although a skilled conductor, sometimes the heart needs help to maintain proper blood flow for musical perfection. To the rescue: Sutter researchers test interventional devices designed to treat patients with diseased or damaged tricuspid and aortic valves.

In one new clinical trial, Sutter researchers will collect information about treatment for severe aortic regurgitation, a condition typically treated with aortic valve replacement surgery.

This study will examine the use of TAVR (Transcatheter Aortic Valve Replacement), a minimally invasive procedure designed to replace the aortic valve inside the heart. In this study, TAVR will be performed using the JenaValve™ Pericardial TAVR System, designed to help treat patients with severe aortic regurgitation or severe aortic stenosis.6

“Until now, all commercially available TAVR valves have focused on aortic stenosis, or a restricted valve,” says Dr. Daniels, co-principal investigator of the TAVR with JenaValve™ clinical trial at Sutter. “The JenaValve™ may allow researchers to treat patients with a leaky valve in the absence of any calcium. Currently these patients are only candidates for open-heart surgery.”

Additionally, Sutter researchers at CPMC and Sutter Medical Center are seeking to enroll patients who have tricuspid regurgitation in a clinical trial called TRILUMINATE.

The TRILUMINATE study will evaluate the safety and effectiveness of the Tricuspid Valve Repair System™ (TVRS) for treating moderate or severe tricuspid regurgitation in patients currently on medical management and who are deemed appropriate for percutaneous transcatheter intervention.7

  • Learn more about Sutter cardiovascular diseases research and clinical trials.
  • If you are suffering from mitral or tricuspid valve regurgitation, aortic valve stenosis or other heart valve disorder, talk to your cardiologist to see if research participation and/or valve replacement or repair is right for you.

References:

  1. American Heart Association.
  2. MitraClip™ is manufactured by Abbott Medical Devices.
  3. The PASCAL clinical trial is sponsored by Edwards Life Sciences, makers of the Transcatheter Valve Repair System®.
  4. The S3 clinical trial is sponsored by Edwards Life Sciences, makers of the SAPIEN M3 System™.
  5. The Summit clinical trial is sponsored by Abbott Medical Devices, makers of the Tendyne System™.
  6. The JenaValve™ clinical trial is sponsored by JenaValve Technology, Inc., makers of the Pericardial Transcatheter Aortic Valve Replacement (TAVR) System.
  7. The TRILUMINATE clinical trial is sponsored by Abbott Medical Devices, makers of the Tricuspid Valve Repair System™.

An Ounce of Prevention, a Hope for Cure of Cervical Cancer

Posted on Dec 30, 2019 in California Pacific Medical Center, Innovation, Quality, Research, Scroll Images, Uncategorized

According to the U.S. Centers for Disease Control and Prevention (CDC), nearly 13,000 women in the U.S. are diagnosed with cervical cancer each year, but the disease can be prevented with vaccination and appropriate screening. Read how researchers in our network are discovering new ways to prevent and treat cervical cancer.

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Study Confirms Accuracy, Ease-of-Use of Personalized Healthcare Cost Estimator

Posted on Dec 13, 2019 in Research, Scroll Images

The results of a 10-month study—published online today in JAMA Network Open—indicate that Sutter Health’s new ambulatory cost estimator tool is easy to use and provides very accurate estimates.

“Healthcare cost transparency is understandably important to our patients,” said study co-author Albert Chan, M.D., M.S., FAAFP, Sutter Health vice president and chief of digital patient experience. “Providing digital tools such as our online cost estimator is another example of our continued commitment to empower our patients with responsive, personalized care.”

Sutter Health’s cost-estimator tool uses real-time data to provide patients with personalized estimates for common ambulatory healthcare services, such as office visits, lab tests or X-rays.

A user survey found the majority of respondents were satisfied with their experience using the cost estimator and would recommend it to others. Survey respondents reported that the tool was intuitive, with one respondent noting, “It’s a relief knowing in advance how much you will be spending on healthcare.”

“Consumers want more information about projected health care costs,” said study co-author Dominick L. Frosch, Ph.D., director and senior scientist at Palo Alto Medical Foundation Research Institute (PAMFRI) and co-director of the Center for Health Systems Research (CHSR). “An accurate cost estimator helps them make informed decisions about their own care and treatment.”

According to PAMFRI and CHSR Assistant Scientists and study co-authors Cheryl D. Stults, PhD, and Jiang Li, PhD, while other health care organizations offer cost-estimator tools, Sutter Health’s is the first of its kind.

“The Sutter tool is unique in that it is integrated with our electronic health record,” Dr. Stults said. “This means it can pull information about a patient’s insurance coverage in real time from the payor and provide a snapshot of approximately what the patient can expect to pay for a service.”

Patients access the tool via Sutter Health’s online patient portal, My Health Online. It provides commercially insured, uninsured and managed care patients estimates for more than 200 ambulatory services. The JAMA report concluded that Sutter had successfully integrated the estimator tool and My Health Online to a high degree of patient satisfaction.

The Cancer Treatment Within You

Posted on Nov 20, 2019 in Affiliates, California Pacific Medical Center, Expanding Access, People, Quality, Research, Scroll Images, Sutter Medical Center, Sacramento, Transformation

How blood, urine and gene mutations may unlock secrets to lung cancer treatment options.

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