Trials / Active Not Recruiting
Active Not RecruitingNCT05155605
PATHFINDER 2: A Multi-Cancer Early Detection Study
The PATHFINDER 2 Study: Evaluating the Safety and Performance of the GRAIL Multi-Cancer Early Detection Test in an Eligible Screening Population
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 35,885 (actual)
- Sponsor
- GRAIL, Inc. · Industry
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Multi-Cancer Early Detection Test | Blood collection and multi-cancer early detection testing with return of results. |
Timeline
- Start date
- 2021-12-08
- Primary completion
- 2026-02-11
- Completion
- 2028-04-30
- First posted
- 2021-12-13
- Last updated
- 2026-04-13
Locations
56 sites across 2 countries: United States, Canada
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05155605. Inclusion in this directory is not an endorsement.