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The PATHFINDER 2 Study: Evaluating the Safety and Performance of the GRAIL Multi-Cancer Early Detection Test in an Eligible Screening Population (GRAIL-012)

Clinical Trial Details

This clinical trial is for adult participants 50 years of age or older who are not currently suspected of having cancer and do not have a personal history of invasive solid tumor or hematologic malignancy (blood cancer) within the past 3 years.
The purpose of this study is to understand the performance of a multi-cancer early detection (MCED) test and the impact of the MCED test on patients and providers. The MCED test is a new test that can be used for early detection of different types of cancers. This test is not yet approved by the U.S. Food and Drug Administration (FDA).
The main goals of this research study are to evaluate how providers will use the results of the MCED test in clinical practice, assess how providers will use the test to direct or recommend additional evaluation, assess participants’ perceptions of risks and benefits of screening with a multi-cancer early detection test, and to evaluate the potential impact of MCED test results on participant’s attitudes towards recommended screening.
The main procedure in this study is the MCED test. The test will be performed via blood drawn from a vein in participant’s arm. Participants will be asked to complete questionnaires throughout the course of the study, which will last approximately 3 years.
Most participants will have a “cancer signal not detected” test result indicating that no cancer signal has been detected. Some participants will have a “cancer signal detected” test result indicating that a cancer signal has been detected, and additional evaluations need to be performed to confirm whether or not the participant has cancer. The study healthcare provider will direct the participant to the appropriate tests or evaluation. If the additional evaluation indicates a cancer diagnosis, the healthcare provider will discuss treatment options with the participant.

Key Eligibility: 
  1. Participants must be at least 50 years of age.
  2. Participants cannot be undergoing or referred for diagnostic evaluation due to clinical suspicion for cancer (e.g., referred to a medical or surgical oncologist, or scheduled for biopsy on the basis of a suspicious imaging abnormality).
  3. Participants cannot have a personal history of invasive solid tumor or hematologic malignancy, diagnosed within the 3 years prior to expected enrollment date, or diagnosed greater than 3 years prior to expected enrollment date and never treated.

Detailed eligibility reviewed when participant contacts the study team.

Study contact by location

Upper East Side - Manhattan



Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:






Open to Enrollment

Age Group