Fred Hutch Cancer Center is spearheading the newly launched Vanguard Study, a groundbreaking national trial evaluating multi-cancer detection (MCD) blood tests for early cancer screening in adults ages 45 to 75. The study represents the first initiative of the Cancer Screening Research Network (CSRN), a nationwide network funded by the National Cancer Institute to advance cancer screening research.
Revolutionary Screening Technology
Multi-cancer detection tests represent a significant advancement in cancer screening technology, using blood samples to detect biological substances released by cancer cells or present in human DNA. The MCD tests being evaluated in the Vanguard study can screen for ten different cancer types: bladder, breast, colorectal, esophageal, stomach, liver, lung, ovarian, pancreatic and prostate cancers.
"There is excitement around these new screening tools with their potential to diagnose cancer earlier, when we expect treatment to be more effective and tolerable," said Ruth Etzioni, PhD, biostatistician at Fred Hutch and one of the principal investigators of the CSRN. "The Vanguard Study and Cancer Screening Research Network will be able to help us understand how these tools are best used."
Addressing Critical Screening Gaps
The study addresses a significant gap in current cancer screening capabilities. While screening tests exist for breast, cervical, colorectal, prostate and lung cancers, most cancers lack any screening methods. According to the American Cancer Society, nearly half of all cancers diagnosed annually are cancers with no recommended screening tests, and these cancers are often found at later stages when they can be harder to treat.
Study Design and Implementation
The Vanguard study will recruit adults ages 45 to 75 with no cancer diagnosis in the past five years. Participants will provide two blood samples—one at entry and another one year later—while continuing regular cancer screening as recommended by their clinicians. The study employs a randomized three-arm design: a control group, a group receiving the Avantect® MCD Test by ClearNote Health, and a group receiving the Shield™ MCD Test by Guardant Health.
"We need to rigorously evaluate multi-cancer detection tests to understand if they're effective and accurate cancer screening tools for everyone," said Scott Ramsey, MD, PhD, principal investigator of the CSRN and cancer researcher at Fred Hutch Cancer Center.
Institutional Expertise and Leadership
Fred Hutch brings extensive experience in leading large-scale clinical trial networks, including the Women's Health Initiative, HIV Vaccine Trials Network, COVID-19 Prevention Trials Network, and serving as the Statistical and Data Management Center for SWOG, a national oncology group. The institution has also led the NCI-sponsored Early Detection Research Network for 25 years.
"Fred Hutch is a leader in team science," said Garnet Anderson, PhD, Director of Public Health Sciences Division at Fred Hutch and one of the principal investigators of the CSRN. "We bring together top scientists and diverse perspectives to answer important public health questions, in this case – do multi-cancer detection tests work? And if so, what are the clinical pathways needed to make an impact on cancer?"
Future Implications
The Vanguard Study serves as a pivotal first step in evaluating the feasibility of conducting large-scale randomized clinical trials to assess MCD test effectiveness and other emerging cancer screening technologies. Its findings will inform the design and implementation of future studies aimed at advancing early cancer detection, including a planned large national trial to determine if MCD tests can decrease cancer burden and mortality.
