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National Cancer Institute Establishes Research Network to Study Cancer Early Detection Tests

NEW YORK – The National Institutes of Health on Wednesday launched a clinical trials research network to evaluate the use of multi-cancer detection tests to help identify cancers early.

The network, called the Cancer Screening Research Network, will initially provide funding through the National Cancer Institute (NCI) to eight institutions to support a pilot study to determine the feasibility of using multi-cancer detection tests in randomized studies. The pilot study, called the Vanguard Study on Multi-Cancer Detection, will enroll up to 24,000 participants to inform the design of a larger, randomized controlled trial. The planned larger trial will explore the potential benefits and harms of using multi-cancer detection tests to screen for cancer and whether the tests can detect cancer early in a way that reduces deaths.

The Vanguard study will have three arms: a control arm that receives standard cancer screening and two arms that receive standard screening plus one of two different multi-cancer detection tests. The aims of the trial are to assess participant willingness for randomization; gauge adherence to testing and diagnostic follow-up; evaluate the feasibility of protocol-defined diagnostic workflows; determine reliability and timeliness of blood specimen testing and return by the diagnostics firms; and identify facilitators and barriers to trial participation for diverse groups. The NCI has not disclosed which multi-cancer detection tests will be included in the trial.

"Our goal is to systematically evaluate cancer screening technologies to understand how best to use them to ultimately save lives," Lori Minasian, deputy director of the division of cancer prevention at NCI, said in a statement. "Data collected through these clinical trials can be used to develop evidence-based guidelines for cancer screening."

The Fred Hutchinson Cancer Center will serve as the coordinating, communications, and statistics and data management center for the trial. Other sites will be opened at Henry Ford Health and Michigan State University Health Sciences; Kaiser Permanente Northern California, Kaiser Permanente Southern California, and Kaiser Permanente School of Medicine; OU Health Stephenson Cancer Center at the University of Oklahoma Health Sciences; the University of Colorado Cancer Center; the University of North Carolina Lineberger Comprehensive Cancer Center; Virginia Commonwealth University and Sentara Health; and Washington University School of Medicine. The Department of Defense Uniformed Services University and the Department of Veterans Affairs will also participate in the trial.

While the initial study will explore multi-cancer early detection tests, the network also plans to evaluate other early detection technologies in the future, such as screening methods that involve imaging, biomarkers, procedures, or combinations of the above, according to the NCI.

There are several diagnostics firms in the multi-cancer early detection space, including Grail, Guardant Health, and Exact Sciences. These liquid biopsy tests screen blood samples for biomarkers associated with cancer, such as circulating tumor DNA. Grail's Galleri test became clinically available in 2021, while Guardant submitted for premarket approval of its Shield assay for colorectal cancer detection last year. Exact Sciences' Cancerguard test to screen for multiple cancers is still in development.