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Vanguard Study Overview | Recruitment Location | Frequestly Asked Questions
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:
- Shield™ MCD Test by Guardant Health, headquartered in Palo Alto, California
- Assay #2
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 MCD Test #2 (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?
Accrual for the Vanguard study will take place at nine CSRN ACCESS Hubs across the U.S. These 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.
The Vanguard Study is a research study that can help us learn more about if new types of blood screening tests for cancer, called multi-cancer detection (MCD) tests, work for people who are eligible to be screened for cancer.
Multi-cancer detection (MCD) tests in this study are designed to detect biological substances released into the bloodstream by cancers cells. Each MCD test screens for several kinds of cancers. No MCD tests screen for every type of cancer. For this study, the cancers being screened for are listed in the consent form that you can review with the study team.
It is important to know that as cancer screening tests, MCDs are not perfect. This means sometimes a test will come back abnormal (or positive) when in fact there is not cancer. In other cases, the MCD test will read negative when cancer is present. When a test comes back abnormal (or positive), further testing will be needed to find out if cancer is present.
Connect with a local research team in your region to discuss your situation further.
This study is the first part of a larger plan to evaluate how well MCD tests work across different communities in the United States. To be successful as a screening test, people must be able to have easy access to the test over time, get their results in a timely fashion, and for those with a positive result, get follow-up tests to determine if they have cancer. Because communities are different, our goal is to learn more about MCD tests and to find out if they can help people from all places and backgrounds find cancer early when it may be easier to treat.
- 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.
- Allow the research team to review their medical record information.
- 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.
Connect with a local research team in your region to discuss your situation further and determine eligibility.
All participants provide a blood sample at enrollment and 1 year after enrollment. Everyone will also fill out 3 questionnaires: at enrollment, 1 year after enrollment and 2 years after enrollment. Some participants will also be asked to fill out a questionnaire approximately 3 months after enrollment and 15 months after enrollment.
Connect with a local research team in your region to discuss their enrollment process.
Yes, we encourage you to continue receiving your usual medical care and currently recommended cancer screenings for you while in the study. Participating in this study will not impact your ability to receive medical care.
Connect with a local research team in your region to discuss your situation further.
Participating in this study does not replace regular cancer screening. It is important to continue with regularly recommended cancer screening.
The blood testing is provided free in this study.
Your health insurance plan may cover the costs of the medical care you get as part of the study. If you need further tests to determine if you have cancer because of the result of your blood test, you may be responsible for copays and deductibles for those tests.
If insurance will not cover further testing, or if you have copays or deductibles related to your diagnostic evaluation, you can let us know and we may be able to reimburse you for those expenses.
Connect with a local research team in your region to discuss your situation further.
You can decide to stop participating in the study at any time, please let your study team know as soon as possible.