Researchers across Virginia and Missouri are launching a pivotal clinical trial to evaluate Multi-Cancer Detection (MCD) tests that could revolutionize cancer screening by identifying up to ten different cancer types through a single blood draw. The Vanguard Study represents a significant step toward addressing the nearly half of all cancers diagnosed annually that currently have no recommended screening tests.
Revolutionary Screening Technology
Multi-Cancer Detection tests work by identifying biological substances released in the bloodstream by cancer cells, offering the potential to screen for multiple cancers simultaneously. According to Dr. Alex Krist, co-principal investigator for the Virginia Cancer Screening Research Network, "It has the potential to have a tremendous impact on our ability to detect cancer early when we can make a difference and improve health outcomes."
The technology targets both cancers with existing screening protocols—including breast, colorectal, lung, and prostate cancers—and those without recommended screenings, such as ovarian, pancreatic, and bladder cancers. Dr. Aimee James, a cancer prevention and control researcher at Siteman Cancer Center, explained that the tests can detect "six to eight cancers" and could identify "ovarian, pancreatic, bladder and other cancers that do have no recommended screenings right now."
Addressing Critical Screening Gaps
The American Cancer Society notes that "nearly half of all cancers diagnosed each year are cancers with no recommended screening tests. These cancers are often found at later stages, when they can be harder to treat." This reality underscores the potential clinical significance of MCD technology in improving early detection rates across multiple cancer types.
Current MCD tests available commercially are not covered by insurance and can cost up to $1,000, making them inaccessible to many patients. The Vanguard Study addresses this barrier by providing free testing to all participants.
Study Design and Participant Requirements
The three-year randomized controlled trial aims to recruit 2,000 participants across Virginia and Missouri. In Virginia, researchers are targeting approximately 600 people in the Richmond-metro area, while Missouri sites are working toward similar enrollment goals.
Eligibility criteria include:
- Ages 45 to 75
- No cancer diagnosis in the past five years
- Not currently pregnant, breastfeeding, or planning pregnancy within one year
Dr. Krist emphasized the study's focus on recruiting diverse populations, stating, "Many of those folks are also the people most in need of cancer screenings. So while this is a study to answer a question, we also want to use it as a way to promote cancer screening in Virginia."
Trial Protocol and Methodology
The study employs a randomized design where participants are assigned either to receive MCD testing or to a control group. "That's the only way we're gonna be able to determine whether there's benefits and risks on these tests," Dr. James explained.
The protocol involves multiple touchpoints over three years. As Dr. Krist detailed, participants "submit a survey, and we collect a blood sample. We repeat that again in a year, repeat the blood sample, do another survey about their health and what they have done for cancer screening, and then a year after that, there is just a survey."
Clinical Considerations and Limitations
Researchers acknowledge important limitations of the technology. The tests under review are expected to detect cancer in fewer than 5% of participants, and false positives and false negatives remain possible outcomes. Dr. James noted, "The limitations are right now it's that they're not gonna pick up everything and there's a lot of cancers out there that multi-cancer detection tests are not going to help us detect."
When positive results occur, additional diagnostic testing will be required, and researchers will assist participants in coordinating follow-up care. Importantly, MCD tests are designed to complement, not replace, existing screening programs. "These are going to be a compliment to your routine cancer screening. This isn't gonna allow us to skip those screenings that are already recommended for us, but compliment and expand to test cancers," Dr. James emphasized.
Future Implications
If the Vanguard Study demonstrates efficacy, researchers plan to launch a larger national trial involving thousands of participants to further evaluate the technology's impact on mortality and survival rates. The potential implications are significant, as Dr. James described: "How exciting would it be for a simple blood test to pick up multiple types of cancers, particularly those cancers that really can instill fear in people because we don't have the screenings for them right now. I think it's a potential game changer."
The study represents a collaborative effort involving the VCU Massey Center, Siteman Cancer Center at Barnes-Jewish Hospital and WashU Medicine, and other institutions across both states. Interested participants can complete subject interest forms through their respective research networks to determine eligibility for this groundbreaking clinical trial.
