Fred Hutch to lead new federal Cancer Screening Research Network

vials of blood — Fred Hutch is leading a new federal consortium to assess the effectiveness of tests that look for evidence of early-stage cancer in blood or other bodily fluids. Getty Images

Fred Hutchinson Cancer Center is at the helm of a new clinical trials consortium, the Cancer Screening Research Network, or CSRN, created by the National Cancer Institute, part of the National Institutes of Health, to advance President Joe Biden’s Cancer Moonshot by improving early detection of cancers.

Biden announced the formation of the Cancer Moonshot, intended to jumpstart progress in research, treating and curing cancer, in 2016 when he was vice president. Six years later, as president, he recommitted to the initiative. The CSRN will play a primary role in moving the Moonshot closer to its goals, which include slashing the age-adjusted death rate from cancer by at least half. The primary focus will be on diagnosing cancer sooner and reducing health inequities — and preventing cancer in the first place — by evaluating new and complex technologies that screen for cancer.

Screening for cancer is a key part of prevention because when more cancers are detected before people develop symptoms, it is expected that treatment — perhaps less aggressive treatment — can lead to better outcomes. Fred Hutch will lead the CSRN’s Coordinating and Communication Center (CCC) and the Statistics and Data Management Center (SDMC) that will oversee cancer screening clinical trials enrolling diverse participants. The initial studies will examine Multi-Cancer Detection assays (MCDs), which look for byproducts of cancer cells in blood or other bodily fluids that could indicate early-stage cancer.

Although these tests are being commercially marketed as effective cancer screening tools, they are so new that there is no research showing they actually work to reduce deaths from cancer. The U.S. Food and Drug Administration has not authorized any MCD tests. But, if research shows that these new blood tests are successful at detecting cancer early and preventing cancer-related deaths, it could help reshape the cancer landscape. Any positive results would need to be confirmed by further testing.

“There is a real urgency to do this research,” said Garnet Anderson, PhD, senior vice president and director of Fred Hutch’s Public Health Sciences Division, who is leading the CCC along with Ruth Etzioni, PhD, and Scott Ramsey, MD, PhD. “There are about 50 companies all developing new kinds of tests, and we feel strongly that they need to be rigorously evaluated before being promoted in the community. We need to know if they’re accurate enough and how physicians can best use them.”

Anderson holds the Fred Hutch 40th Anniversary Endowed Chair, and Etzioni holds the Rosalie and Harold Rea Brown Endowed Chair.

Etzioni said that the new network is critical to keeping patients well-informed.

“That NCI is taking this on reflects their awareness of the potentially practice-changing nature of these technologies,” she said. “We are very proud to be partnering with them in making sure that people have the information they need to optimally manage their health.”

Collecting and analyzing the data

The SDMC will be led by Charles Kooperberg, PhD, Ziding Feng, PhD and Katherine Guthrie, PhD. Additional CCC investigators include Charles Drescher, MD, Vida Henderson, PhD, PharmD, Rachel Issaka, MD, MAS, Paul Lampe, PhD and Matthew Triplette, MD, MPH. Issaka holds the Kathryn Surace-Smith Endowed Chair in Health Equity Research. Ying Huang, PhD, and Catherine Tangen, PhD, round out the SDMC team.

The CCC will develop study protocols and train and monitor the nine U.S. organizations that will recruit participants, while the SDMC will lead the statistical designs and manage and analyze the vast amounts of data generated.

“Organizing all this data is not a simple matter,” said Kooperberg. “The key for understanding the value of cancer screening is to look at mortality; that takes a long time.”

He noted that it’s crucial to make sure the tests don’t do harm. What if people taking these tests decide not to pursue other evidence-based screening such as mammograms or colonoscopies? Could the tests detect cancers that don’t require treatment?

“If these tests only identify cancer that you die with and not from, that’s not a good thing,” he said.

Fred Hutch has a long history of spearheading trial coordination efforts and data management for pivotal federal research. Fred Hutch coordinates the Women’s Health Initiative, or WHI, which recruited 160,000 women starting in 1993 and is among the most comprehensive prevention studies in the U.S. The WHI has generated and supported hundreds of research studies. Fred Hutch also leads study design and data collection and analysis for the NCI’s SWOG Cancer Research Network, a similarly structured group for 100 cancer treatment trials.

The evaluation of blood tests for cancer early detection is much more complex than one might think. Fred Hutch has been at the forefront of developing and supporting rigorous studies to evaluate novel cancer screening methods, largely in its role as the data coordinating center for the NCI’s Early Detection Research Network, where both Feng and Etzioni have held key leadership roles.

Initial research will study healthy people

The CSRN will begin its work this year by launching the Vanguard study to recruit and enroll healthy participants between the ages of 45 and 70 and assess a small number of MCD tests. A larger trial may follow that has yet to be designed but would likely involve more people and examine more tests. The goal of both studies is to determine if the tests decrease illness and death due to cancer.

There are many unanswered questions: Will people who get a negative MCD result stop standard-of-care screening such as colonoscopies or mammograms? How will those people who get a positive result react if diagnostic tests don’t reveal cancer? How should physicians handle MCD test results that may produce false positives? Will MCD tests find slow-growing cancers that never would have required any type of cancer treatment in the first place? And will these blood tests prove prohibitively expensive to many people, further exacerbating health disparities?

Those are all areas of inquiry for the new network.

“NCI has launched CSRN to evaluate a variety of different technologies for the purpose of cancer screening,” said Lori M. Minasian, MD, deputy director of NCI’s Division of Cancer Prevention. “Detecting cancer early is not enough to improve people’s lives. Through CSRN, we're going to study whether using these new technologies will make a difference in people’s lives.”

A key focus of the CSRN will involve health equity. For starters, federal programs such as Medicare and Medicaid that insure some of the most vulnerable populations won’t cover MCDs unless they’re shown to be of value. And ensuing diagnostics and treatment can incur enormous medical expenses, potentially exacerbating health disparities.

Along these same lines, the CSRN aims to engage a wide range of U.S. communities so that the results are meaningful and potentially beneficial for all.

“Companies are pushing these tests to market,” said Feng. “NCI wants to be an unbiased broker and make sure we have very solid evaluations of these tests.”

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