Active — Not RecruitingNot Applicable

PATHFINDER 2: A Multi-Cancer Early Detection Study

United States, Canada35,883 participantsStarted 2021-12-08

Plain-language 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.

Who can participate

Age range

50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Participants must be at least 50 years of age, inclusive, at the time of signing the Informed Consent Form (ICF).
. Participants must be capable of giving signed and legally effective informed consent

Exclusion criteria

. 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.
. Prior/Concurrent Concomitant Therapy (Medications/Treatments):

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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).

Timeframe: Up to 3 Years

Test performance: diagnosis of invasive cancer, assessed by positive predictive value (PPV).

Timeframe: Up to 3 Years

Test performance: diagnosis of invasive cancer, assessed by negative predictive value (NPV).

Timeframe: Up to 3 Years

Test performance: diagnosis of invasive cancer, assessed by sensitivity.

Timeframe: Up to 3 Years

Test performance: diagnosis of invasive cancer, assessed by specificity.

Timeframe: Up to 3 Years

Test performance: diagnosis of invasive cancer, assessed by cancer signal origin (CSO) accuracy.

Timeframe: Up to 3 Years

Trial details

NCT IDNCT05155605

SponsorGRAIL, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-02-11

View on ClinicalTrials.gov More Early Detection of Cancer trials

Plain-language summary

Who can participate

Age range

50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Participants must be at least 50 years of age, inclusive, at the time of signing the Informed Consent Form (ICF).
. Participants must be capable of giving signed and legally effective informed consent

Exclusion criteria

. 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.
. Prior/Concurrent Concomitant Therapy (Medications/Treatments):

What they're measuring

Timeframe: Up to 3 Years

Test performance: diagnosis of invasive cancer, assessed by positive predictive value (PPV).

Timeframe: Up to 3 Years

Test performance: diagnosis of invasive cancer, assessed by negative predictive value (NPV).

Timeframe: Up to 3 Years

Test performance: diagnosis of invasive cancer, assessed by sensitivity.

Timeframe: Up to 3 Years

Test performance: diagnosis of invasive cancer, assessed by specificity.

Timeframe: Up to 3 Years

Test performance: diagnosis of invasive cancer, assessed by cancer signal origin (CSO) accuracy.

Timeframe: Up to 3 Years