NCT04241796

Assessment of the Implementation of an Investigational Multi-Cancer Early Detection Test Into Clinical Practice

The PATHFINDER Study: Assessment of the Implementation of an Investigational Multi-Cancer Early Detection Test Into Clinical Practice

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 6,662 (actual)
• Sponsor: GRAIL, Inc. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

Summary

PATHFINDER is a prospective, multi-center study in which approximately 6,200 participants will be enrolled. An investigational multi-cancer early detection test, developed by GRAIL, will be ordered by and results returned to a study investigator. In cases with a "signal detected" test result (with a predicted or indeterminate tissue of origin (TOO)), the diagnostic work-up will not be dictated by the protocol, but will instead be coordinated by the ordering and treating medical team at the enrolling sites based on the participant's clinical condition, recommendations by each institution's clinical practices, and in consultation with the study investigator and interdisciplinary care team, as necessary. Additionally, proposed clinical care pathways, developed based on a review of guidelines from the National Comprehensive Cancer Network (NCCN), American College of Radiology (ACR) and other professional organizations, should be referenced by the medical team to determine the diagnostic work-up. The number and types of diagnostic procedures required to achieve diagnostic resolution will be assessed. Performance of multi-cancer early detection test will be evaluated. Additionally, participant-reported outcomes will be collected at several time points to assess participants' perceptions about the multi-cancer early detection test. Participants will be followed for approximately 12 months from the time of enrollment. Cancer status will also be assessed at the 12 month time point.

Conditions

• Cancer

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: 2019-12-12
• Primary completion: 2021-12-01
• Completion: 2022-01-05
• First posted: 2020-01-27
• Last updated: 2022-10-25

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated device study