This study will look at the use of new technologies for cancer screening called Multi-Cancer Detection (MCD) tests. The goal is to learn more about these tests and find out if they can help people from all backgrounds to find cancer early when it may be easier to treat.
The National Cancer Institute (NCI) completed a process to engage MCD assay developers, and two assays (tests) were selected, in alphabetical order, for the Vanguard Study are:
- Avantect MCD Test by ClearNote Health, headquartered in San Diego, California
- Shield™ MCD Test by Guardant Health, headquartered in Palo Alto, California
These two assays will not be compared to each other but will be compared to cancers detected in the Control Arm. The companies will provide the tests without cost to the study participants.
In this study, participants will be randomly assigned to one of three groups: the Intervention Group 1, the Intervention Group 2, or the Control Group. All participants will receive standard cancer screenings as part of their care.
- Arm 1 Shield™ MCD test (Intervention Group 1): Participants will receive the MCD test labeled 1.
- Arm 2 Avantect MCD test (Intervention Group 2): Participants will receive the MCD test labeled 2.
- Arm 3 No MCD test (Control Group): Participants will not receive any MCD tests.
The study aims to:
- Learn if participants are okay with being randomly assigned to different groups.
- See if participants follow the testing and check-up schedules.
- Test if the planned steps for diagnosis work well.
- Make sure blood tests are done correctly and results come back on time.
- Find out what helps or makes it hard for different people to join, stay in, and follow the study rules.
What are ACCrual, Enrollment, and Screening Sites (ACCESS) Hubs?
The CSRN ACCESS Hubs are specialized centers contributing to the National Cancer Institute's cancer screening research effort. They bring together different healthcare teams, located in different part of the U.S., to find and sign up eligible participants for cancer screening studies. These hubs work with many hospitals and clinics to ensure a representative group of people can join and stay informed throughout the course of the Vanguard Study. The goal is to discover new ways to detect cancer early and improve cancer screening.
- Ages 45-75 years old.
- Do not currently have a cancer diagnosis and have not received a cancer diagnosis within the past 5 years.
- Willing to give blood samples at enrollment and after 1 year.
- Understand and be able to complete study documents in English, Spanish, or Arabic.
- Not currently breastfeeding, pregnant, or planning to become pregnant within the next year.
- Not currently participating in another study testing a new cancer screening method or technology.
We encourage you to contact a local study team to discuss your situation further. Find an ACCESS Hub in your region.
In general, CSRN studies will try to include people who would benefit from cancer screening. Each ACCESS Hub will ensure their enrolled participants are reflective of the communities they serve.
The Vanguard Study is looking for people who do not currently have cancer and have not received a cancer diagnosis within the past 5 years.
We encourage you to contact a local study team to discuss your situation further. Find an ACCESS Hub in your region.
The Vanguard Study will recruit people who do not currently have cancer and have not received a cancer diagnosis within the past 5 years. People with other health conditions can join as long as their conditions do not stop them from being able to complete the study steps.
We encourage you to contact a local study team to discuss your situation further. Find an ACCESS Hub in your region.
The Vanguard Study will look for people who do not currently have cancer and have not received a cancer diagnosis within the past 5 years.
People with high risks of cancer are not excluded from participating.
We encourage you to contact a local study team to discuss your situation further. Find an ACCESS Hub in your region.
The Vanguard Study does not recruite people who are currently taking part in another study that is testing a new cancer screening method or technology.
We encourage you to contact a local study team to discuss your situation further. Find an ACCESS Hub in your region.
- January 2022: NCI released a request for information (NOT-CA-22-033) to assess both the availability and readiness of MCD tests for inclusion in the Vanguard Study and gauge assay developers' interest.
- May 2023: NCI hosted a public workshop (NOT-CA-23-055) to engage MCD assay developers and invited them to apply for inclusion in the Vanguard Study.
- Application Process: Assay developers submitted formal applications.
- Performance Verification: Selected assays underwent a performance verification process.
- Blinded Reference Set: NCI provided a blinded reference set for testing on specimens from the Alliance for Clinical Trials in Oncology.
- Results Submission: Companies sent their results back to NCI for analysis.
- Publication: Results from the NCI verification study will be published in 2025.
- ClearNote Health is a privately held company dedicated to improving early detection and monitoring for some of the deadliest forms of cancer. Developed by scientists in the Stephen Quake laboratory at Stanford University, the company’s patented core Virtuoso® epigenomics platform builds on the latest advances in artificial intelligence and bioinformatics to measure active biological differences between cancer and healthy cells in a blood sample. The company’s highly sensitive, noninvasive Avantect® Pancreatic and Ovarian diagnostic tests are designed to identify cancers in high-risk patient populations far earlier than conventional approaches, when patients are most likely to benefit from treatment. ClearNote Health’s headquarters and CLIA-certified, CAP-accredited laboratory are located in San Diego. For more information, visit www.clearnotehealth.com or follow the company on X or LinkedIn.
Read ClearNote Health's press release
- Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant is transforming patient care and accelerating new cancer therapies by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and treatment selection for patients with advanced cancer. For more information, visit www.guardanthealth.com and follow the company on LinkedIn, X (Twitter) and Facebook.
Read Guardant Health's press release