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NCT05155605 · ClinicalTrials.gov registry record · NA
PATHFINDER 2: a Multi-Cancer Early Detection Study
A NA study of Cancer and Early Detection of Cancer, sponsored by GRAIL.
- Active
- Registry status
- NA
- Development phase
- 35,885
- Enrollment target
- 20
- Study locations
NCT05155605 is a NA study of Cancer and Early Detection of Cancer that is active but no longer recruiting, run by GRAIL. The registered enrollment target is 35,885 participants, above the 3,433-participant average among 615 other Cancer trials with a reported enrollment target (945% higher). The trial reports 20 study locations across 7 states.
The verdict
NCT05155605, a NA study of Cancer and Early Detection of Cancer, is active but no longer recruiting, sponsored by GRAIL.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 35,885 participants
- Enrollment target
- 20
- Study locations
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.
Conditions Studied
Interventions
- DEVICE Multi-Cancer Early Detection Test
Study Locations (20)
California
- Sutter Health - Auburn
- Sutter Health - Davis
- Sutter Health - Elk Grove
- Sutter Health - Fairfield
- HOAG Irvine - Irvine
- HOAG Vivante Newport Mesa - Irvine
- Long Beach Memorial Medical Center - Long Beach
- Sutter Health - Modesto
- HOAG Newport Beach - Newport Beach
- Palo Alto Medical Foundation - Palo Alto
- Sutter Health - Sacramento
- PAMF - Santa Cruz - Santa Cruz
- PAMF - Sunnyvale - Sunnyvale
Louisiana
- Ochsner Grove - Baton Rouge
- Ochsner Lafayette General - Lafayette
Colorado
- Sarah Cannon Research Institute - Englewood Primary Care - Englewood
District of Columbia
- Medstar Washington Hospital Center - Northwest
Florida
- Woodlands Medical Specialists - Pensacola
Georgia
- Morehouse School of Medicine - Atlanta
Illinois
- University of Illinois at Chicago - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35,885 participants |
| Start Date | 2021-12-08 |
| Est. Completion | 2028-04-30 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05155605
The ClinicalTrials.gov registry entry for NCT05155605 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 35,885 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 3,433-participant average among 615 other Cancer trials with a reported enrollment target (945% higher). The listed sponsor is GRAIL, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Cancer appearing as the primary indexed condition, and to 1 intervention - of which Multi-Cancer Early Detection Test is the first listed.
NCT05155605 reports 20 study locations spanning 7 distinct geographic areas - top geographies include California, Louisiana, Colorado.
Frequently Asked Questions
What is clinical trial NCT05155605 about?
NCT05155605 is a clinical study titled "PATHFINDER 2: a Multi-Cancer Early Detection Study". 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...
What is the current status of trial NCT05155605?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 35,885 participants. The study started on 2021-12-08. Estimated completion is 2028-04-30.
What conditions does trial NCT05155605 study?
This clinical trial studies the following conditions: Cancer, Early Detection of Cancer.
What interventions are being tested in trial NCT05155605?
The interventions under investigation include: Multi-Cancer Early Detection Test (DEVICE).
Who is sponsoring clinical trial NCT05155605?
This trial is sponsored by GRAIL, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05155605 being conducted?
This trial has 20 study locations across California, Colorado, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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