General

How long will I be in the study?

You will be in the study for up to 3 years.

How many study visits will I have?

Most participants will have about 2 study visits—first, at the study site to have a blood test, and a second visit may occur if you need to come back for a research blood draw. The study team may discuss your study test result with you in-person, by phone call, or by virtual visit.

If your test result shows a cancer signal detected, you will have additional visits for tests to determine whether or not you have cancer.

What are the benefits of being in the clinical study?

You may or may not directly benefit from being in the study, but any information learned will help to develop a test that can catch cancer early in other people in the future. Some participants who receive a “cancer signal detected” test result may go on to have additional tests that lead to a diagnosis of cancer.

Are there any risks to participating in the study?

There is a chance that the study test may produce inaccurate results in some cases. Inaccurate “cancer signal detected” results could lead to unnecessary testing and additional anxiety.

Not all cancers can be detected by the study test. False-negative (a cancer signal not detected when cancer is present) test results do occur.

You may experience risks and discomforts associated with the study procedure and/or the blood test, such as lightheadedness, or slight bleeding or bruising at the blood draw site.

Will being in the study cost me?

Participating in the study will not cost you anything. The multi-cancer early detection test will be provided to you at no cost. If you receive a test result of “cancer signal detected”, the study sponsor will cover the costs of the tests and procedures ordered by the healthcare provider until the healthcare provider confirms whether or not cancer is present.

Who is sponsoring the study?

The healthcare company GRAIL, whose mission is to detect cancer early when it can be cured, is sponsoring the PATHFINDER 2 Study. GRAIL pays the study doctors and study sites to run this study.

What if I decide to join the study and then change my mind?

Being in the study is completely voluntary. If you decide to join the study and then change your mind, you can leave the study at any time.

Study Test Questions

Can I get the test outside of the study?

The study test is currently not approved by the FDA, however, it is commercially available. You can request the test from your healthcare provider, but you will be responsible for the cost.

Will I receive any treatment during the study?

No, this study is not a treatment study. The PATHFINDER 2 Study is looking at a blood test for early detection of cancer.

What will the study test results tell me?

Your study test result will tell you whether or not a cancer signal was detected in your blood by the study test. If a cancer signal is found, the test will predict what part of the body the cancer may be coming from. Based on these results, your healthcare provider will decide if you need additional tests. This study does not replace any cancer screening tests that your healthcare provider recommends. You should continue to have all other recommended cancer screening tests.

What happens if the study test detects a cancer signal?

If you receive a study test result of “cancer signal detected,” your healthcare provider will direct you to the next appropriate test or evaluation to confirm whether or not cancer is present. This test result is not a diagnosis of cancer. Only additional tests can provide a confirmed diagnosis of cancer. The study team will collect information about the additional tests and procedures your healthcare provider orders and the results of these tests.

Does this study replace recommended cancer screening tests?

No, this study does not replace any cancer screening tests that your healthcare provider recommends. You should continue to have all other recommended cancer screening tests.