A new clinical trial is investigating whether a routine blood test could eventually replace multiple cancer screening procedures, detecting signals from several deadly cancers at the same time. The Vanguard Study, led by researchers at UNC Lineberger Comprehensive Cancer Center, is recruiting 2,000 North Carolinians to evaluate blood-based tests designed to catch cancers earlier, including those that currently have no standard screening method.

What Cancers Currently Have No Routine Screening?

Today, evidence-based screening guidelines exist for only four major cancer types: lung, breast, colorectal, and cervical cancer. But several other deadly forms lack routine screening methods, leaving patients vulnerable to late-stage diagnoses. Pancreatic cancer, ovarian cancer, and stomach cancer fall into this gap, making early detection nearly impossible with current tools.

This screening gap is deeply personal for Marla Mills-Wilson, a Youngsville mother of two who was diagnosed with stage two pancreatic cancer last year. Despite keeping up with regular physicals, seeing a gastroenterologist, and undergoing genetic testing, her cancer was not caught by screening. Instead, a subtle symptom,amber-colored urine,eventually led to her diagnosis. "Early detection is everything," Mills-Wilson said, reflecting on her experience.

How Do Multi-Cancer Detection Blood Tests Work?

The Vanguard Study is evaluating a newer screening technology called multi-cancer detection assays, or MCDs. Unlike traditional screening tests that look for one type of cancer, these blood-based tests are designed to detect signals from multiple cancers simultaneously.

The study is testing two different MCD assays. Participants are randomly assigned to one of three groups: two groups receive different MCD assays, while the third serves as a control group. For participants assigned to receive an MCD assay, any positive cancer signal is reported back to them and their doctor so they can undergo additional testing.

"What's really cool about them is that they are what we call blood-based. They are a tube of blood that can be very easily drawn. That is then used to screen for multiple cancers at once," explained Dr. Carrie Lee, a thoracic medical oncologist and chief medical officer for clinical research at UNC Lineberger Comprehensive Cancer Center.

Dr. Carrie Lee, Chief Medical Officer for Clinical Research, UNC Lineberger Comprehensive Cancer Center

Researchers will track what happens after a test identifies a possible cancer signal, measuring how often patients are actually diagnosed with cancer and what follow-up steps they take.

Steps to Participate in Cancer Screening Research

• Age Requirement: Adults between 45 and 75 years old are eligible, provided they have not had a cancer diagnosis within the past five years
• Blood Collection: Participants provide blood samples at the beginning of the study and again one year later, with collection sites available in Chapel Hill, Hillsborough, and at UNC Health Southeastern in Lumberton
• Remote Participation: Parts of the study can be completed remotely, and participants do not necessarily have to travel to Chapel Hill to participate
• Contact Information: Interested individuals can reach the Vanguard Study team at LCCC_VanguardStudy@med.unc.edu or by calling (919) 843-4863

Why Is This Research Important Right Now?

The Vanguard Study is part of a larger National Cancer Institute-funded Cancer Screening Research Network. UNC Lineberger is one of nine hubs across the country, with each hub enrolling about 2,000 participants. This brings the pilot study to roughly 18,000 to 20,000 participants nationwide, with results expected to inform a much larger clinical trial potentially involving around 200,000 people.

Currently, no FDA-approved multi-cancer detection assays exist, although some are commercially available for roughly $700 to $1,000 out of pocket. However, Dr. Lee cautioned that this technology remains experimental and not yet established medical practice.

"There may be a time in the future that cancer screening is perhaps less about mammograms and colonoscopies, and more about having a blood test. For some patients, that's really attractive because some of those tests and procedures can be associated with time off work and things like that," said Dr. Carrie Lee.

Dr. Carrie Lee, Chief Medical Officer for Clinical Research, UNC Lineberger Comprehensive Cancer Center

For now, Dr. Lee emphasized that people should continue getting their recommended screening exams, including Pap smears, CT scans, mammograms, and colonoscopies. "It's not ready for primetime yet," she noted. "There's lots of promise, but we don't want to overhype".

Dr. Lee

Who Should Participate in This Research?

The North Carolina hub has already enrolled more than 600 people toward its goal of 2,000, with enrollment expected to remain open for at least another year. Researchers are specifically trying to recruit participants who reflect the diversity of North Carolina, including people outside the Triangle and across racial and socioeconomic backgrounds.

"We want to make sure that our results that we learn from the study are applicable to the entire population," Dr. Lee explained. Mills-Wilson, who has spent 30 years working behind the scenes of clinical trials, stressed the importance of including people from different backgrounds. "The more people we have to participate in clinical trials of all ethnicities, walks of life, the better it is for cancer," she said.

Dr. Lee

For Mills-Wilson, who underwent Whipple surgery after her tumor shrank dramatically in response to a new drug being studied in a separate UNC clinical trial, participating in research has become a personal mission. She now returns to UNC every three months for scans and blood work and encourages others to consider joining the Vanguard Study. "No one wants to be diagnosed with cancer," she said. "Early detection is everything".