PATHFINDER 2 Study
What Is PATHFINDER 2?
PATHFINDER 2 Overview
Cleveland Clinic is participating in the PATHFINDER 2 Study, a clinical trial that aims to detect cancer earlier, through a single blood test. Developed by GRAIL (also the study sponsor), this blood test is designed to detect more than 50 cancers, as well as their location in the body, before symptoms are present, all with a very low false positive rate.
Too often, cancer goes undetected until it is at an advanced stage. Thinking about the possibility of having cancer can feel overwhelming, but taking steps to find cancer early can help you feel more in control of your health. The earlier that cancer is found, the higher the chance of survival. The PATHFINDER 2 Study will evaluate the performance of a multi-cancer early detection test, called Galleri®, which can detect many types of cancer through a simple blood draw. This test is being studied and is not approved or cleared by the Food and Drug Administration (FDA). It is not meant to replace the cancer screening tests your healthcare provider may recommend, such as colonoscopy or mammography. Missing recommended screening or ignoring symptoms could lead to a delayed diagnosis of cancer.
How does the PATHFINDER 2 study work?
PATHFINDER 2 is a research study to see how well the Galleri® test works to detect cancer earlier. The study aims to measure the benefits and safety of the test in people who are eligible for cancer screening. The Galleri® test detects many types of cancer, including several cancers that are not commonly screened for today. This information will help guide healthcare providers to determine the appropriate diagnostic test(s) to confirm whether cancer is present.
Why should I participate?
Despite many advances, cancer remains the second leading cause of death worldwide. Today, there is no screening available for the majority of life threatening cancers, and as a result, most cancers are not detected until too late when outcomes are poor. The earlier cancer is diagnosed, the better the chance of successful treatment, but cancer can spread and grow before any symptoms arise.
The PATHFINDER 2 study will contribute to a greater understanding of how this test may be implemented in routine health care to help more people increase their chances of finding cancer early, when treatment is more likely to be successful. Your participation in clinical trials could make a difference for your family and your community, as well as improve treatment outcomes for cancer patients around the world.
Who is eligible to participate?
The study is currently open to men and women aged 50 years or older who are either:
- Healthy individuals at an average risk for cancer.
- Individuals with an increased risk of cancer, meaning they:
- Have smoked at least 100 cigarettes in their lifetime.
- Have a known genetic syndrome (BRCA, HNPCC, Lynch, etc.) that increases cancer risk.
- Have been treated for an invasive cancer at least three years ago, and are currently cancer-free.
- Participants in previous or ongoing GRAIL sponsored studies are not eligible to participate in the PATHFINDER 2 study.
If you are interested in finding out if you are a candidate for the study, please complete the form at the bottom of this page. A study coordinator will be in contact to discuss your eligibility and next steps. If eligible, the initial consultation will be conducted virtually, and an appointment for a blood test will be scheduled. You must have a scheduled appointment for a blood test.
We also recommend you review our consent document, which provides additional details on the study. Please note, this document is for review purposes only. Once you are contacted by the coordinator and eligible for the study, you will be provided a consent form to sign.
PATHFINDER 2 is a research study using Galleri ®, a blood test which is not yet approved by the FDA being conducted under an investigational device exemption (IDE) application. The test is intended to be complementary to, and not a replacement of, U.S. guideline-recommended cancer screenings your healthcare provider may recommend, such as colonoscopy or mammography.
I'm interested in learning more. How do I get started?
Interested in finding out if you are a candidate for PATHFINDER 2? Please complete the form below and a member of our research team will contact you.