PATHFINDER 2: A Multi-Cancer Early Detection Study

Condition(s) studied

Investigational drug(s) / intervention(s)

Multi-Cancer Early Detection Test: Blood collection and multi-cancer early detection testing with return of results.

Study summary

This is a prospective, multi-center interventional study of the GRAIL multi-cancer early detection (MCED) test with return of test results for participants enrolled through healthcare systems in North America. The purpose of this study is to evaluate the safety and performance of the GRAIL MCED test in a population of individuals who are eligible for guideline-recommended cancer screening. In cases with a "cancer signal detected" test result, participants will undergo diagnostic procedures based on the test returned cancer signal origin(s) to determine if they have cancer. The number and types of diagnostic procedures required to achieve diagnostic resolution will be assessed. Participant-reported outcomes will be collected at several time points to assess participants' perceptions about the multi-cancer early detection test.

The study will enroll approximately 35,000 and no more than 38,500 participants as defined by eligibility criteria over an anticipated enrollment period of approximately 36 months at up to 40 clinical institutions within North America. Participants will be actively followed for approximately 3 years from the date of their enrollment.

Eligibility

Primary outcome measure(s)

• Safety: Number and type of invasive procedures performed in participants with a cancer signal detected by the multi-cancer early detection (MCED) test and no cancer diagnosis at the time of diagnostic resolution (i.e., false positive test result). — Up to 3 Years
• Test performance: diagnosis of invasive cancer, assessed by positive predictive value (PPV). — Up to 3 Years
• Test performance: diagnosis of invasive cancer, assessed by negative predictive value (NPV). — Up to 3 Years
• Test performance: diagnosis of invasive cancer, assessed by sensitivity. — Up to 3 Years
• Test performance: diagnosis of invasive cancer, assessed by specificity. — Up to 3 Years
• Test performance: diagnosis of invasive cancer, assessed by cancer signal origin (CSO) accuracy. — Up to 3 Years
• Test performance: diagnosis of invasive cancer, assessed by observed cancer detection rate (CDR). — Up to 3 Years
• Test performance: diagnosis of invasive cancer, assessed by number needed to screen to detect an invasive cancer (NNS). — Up to 3 Years

Trial sites (56)

+ 16 more sites — see the full list on the official registry below.

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