Vanguard

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. We will study whether multi-cancer detection tests (MCDs) 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 cancer. 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 may come back abnormal (or positive) when in fact there is not cancer. When a test comes back abnormal (or positive), further testing will be needed to find out if cancer is present. In other cases, the MCD test will read negative when cancer is present. For this reason, it’s important to keep doing any routine screening tests your doctor recommends.

(See Question 12 for more information on what will happen if you have an abnormal or positive MCD test in this Study).

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 easily access the test, 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.

Adults between the ages of 45-75 who do not currently have cancer and have not had a cancer diagnosis in the past 5 years. Participants must be willing to provide blood samples twice: at enrollment and 1 year after enrollment. They also must complete questionnaires and allow the research team to review their medical record information.

Participants should not currently be in an evaluation to see if they have cancer (for example from a positive mammogram or because a doctor is evaluating symptoms that might suggest cancer). They also should not be in another cancer screening study or getting a different MCD test. Women should not be breastfeeding or pregnant.

For eligibility questions, contact 417-269-7114.

If you are not able to give blood, you will not be eligible to participate in this study.

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.

Contact our study team at 417-269-7114.

The Vanguard Study has three study groups. Groups 1 and 2 will have their blood tested using a MCD test and Group 3 will have their blood stored but not tested. We will use a computer to assign you to one of the three study groups. This process is called “randomization.” You will have an equal chance of being in Group 1, Group 2, or Group 3.

You will receive an MCD test after your blood draw at enrollment and again at year 1 if you are assigned to Group 1 or Group 2.

Yes, you will know if your blood is tested. Your study care team will receive the results of your MCD test and share them with you. If you have an abnormal (or positive) MCD result, your study care team will contact you to discuss next steps.

About 1 month after your blood draw, your study care team will receive the results and share them with you.

A positive result means the test found a possible signal for cancer in your blood, but it doesn’t always mean you have cancer. More testing will be needed to learn more. If this happens, a nurse navigator from our study team will call you to explain the results and help guide you through the next steps. You won’t be alone – we’re here to support you throughout the process.

If your test is positive for a possible cancer signal, your primary care provider will be notified of the results. Our study team will manage your follow-up testing. If you wish to schedule a visit with your primary care provider, the cost of the that visit would not be included in this study.

Yes, we encourage you to continue receiving your usual medical care and any recommended cancer screenings for you while in the study. Participating in this study will not impact your ability to receive medical care.

Participating in this study does not replace regular cancer screening. It is important to continue with regularly recommended cancer screening.

If your MCD test result is positive, the study team will help guide you through the next steps for follow-up testing. The study will cover the cost of study-related diagnostic follow-up testing at Washington University regardless of your ability to pay. If you are diagnosed with cancer, your care will be provided by doctors and specialists who treat that specific type of cancer. Please note that the study does not cover the cost of any cancer treatment you may need during or after the study.

No. While you are in this study you should not access another MCD test.

Yes, you can continue to participate if you move. Please contact us at 417-269-7114 to discuss options if you do move, including where to complete your second blood draw and how we can contact you to complete study questionnaires.

Your blood will be collected through a standard blood draw. You will be asked to provide a sample of about three tablespoons of blood twice during the study. Blood draws will take place at Saint Luke's Cancer Institute at Saint Luke's Hospital of Kansas City located on the plaza. A skilled research nurse will perform the procedure, and a member of our study team will be there to support you throughout your visit.

If you are in Groups 1 or 2, some of your blood will be sent to the MCD companies to perform the MCD test and some of your blood will be sent to a laboratory, run by the National Cancer Institute, for storage during the study. If you are in Group 3, all of your blood will be sent to the laboratory for storage during the study.

Any blood that is sent to one of the MCD companies and is left over after MCD testing will be destroyed.

For the blood that is sent to the laboratory, you have the option to participate in future studies and have any remaining blood saved (this is called “biobanking”). The study team will discuss this option with you when you review the consent form so you can decide if you would like to participate in biobanking. If you decide not to participate in biobanking, any remaining blood sample that was stored at the laboratory will be destroyed at the end of the study.

The blood testing is provided free in this study.  If your study-provided MCD test is abnormal, we will cover the cost of study-related diagnostic follow-up testing at Washington University regardless of your ability to pay.

We are committed to ensuring appropriate follow-up to an abnormal MCD test to the point of cancer diagnosis, the point cancer is ruled out, or when no further study-related testing is recommended. However, we will not cover the cost of routine cancer screening tests that you may be eligible for, which can be performed at any healthcare facility.