Posts by Karin

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.

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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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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When Online Matchmaking and Cancer Treatment Collide

Posted on Nov 19, 2019 in Affiliates, Expanding Access, Innovation, Quality, Research, Scroll Images, Transformation

More than 600 types of drugs exist to treat cancer. A new tool will help doctors supercharge their searches for the ones that will work best for their patients.

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