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

The purpose of this study is to understand the performance of a multi-cancer early detection (MCED) test (manufactured by GRAIL, LLC) and the impact of the MCED test on participants and providers. The MCED test is a new test being developed for early detection of different types of cancers. This test is not approved or cleared by the Food and Drug Administration (FDA).

The main goals of this research study are to evaluate how study healthcare providers will use the results of the MCED test in clinical practice, assess how study healthcare 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.

Inova Schar Cancer Institute – Saville Cancer Screening and Prevention Center
8081 Innovation Park Dr.
Fairfax, VA 22031

A department of Inova Fairfax Hospital

• 50 years of age or older
• Capable of giving signed and legally effective informed consent
• Additional eligibility in protocol.

• 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).
• 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.
  • Individuals with a diagnosis of non-metastatic basal cell carcinoma and squamous cell carcinoma of the skin are not excluded.
• Prior/Concurrent Concomitant Therapy (Medications/Treatments):
  • Definitive treatment for invasive solid tumor or hematologic malignancy within the 3 years prior to expected enrollment date. Adjuvant hormone therapy for cancer (e.g. for breast or prostate cancer) is not an exclusion criterion.
• Individuals who are not currently registered patients at a participating center.
• Previous or current participation in another GRAIL-sponsored study. "Participation" is defined as having signed consent and provided a blood sample.
• Previous or current employees or contractors of GRAIL
• Current pregnancy (by self-report of pregnancy status)
• Additional ineligibility in protocol

For more information, go to: https://clinicaltrials.gov/ct2/show/NCT05155605