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

October 22, 2022 updated by: GRAIL, LLC

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6662

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Roseville, California, United States, 95661
        • Sutter Health
    • Florida
      • Pensacola, Florida, United States, 32503
        • Woodlands Medical Specialists, PA
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana-Farber Cancer Institute
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Rochester
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Willamette Valley Cancer Institute
      • Portland, Oregon, United States, 97201
        • Oregon Health & Science University
    • Texas
      • Amarillo, Texas, United States, 79106
        • Texas Oncology, PA (West TXO)
    • Utah
      • Saint George, Utah, United States, 84790
        • Intermountain Healthcare Research
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Virginia Cancer Specialists, PC
    • Washington
      • Vancouver, Washington, United States, 98684
        • Northwest Cancer Specialists, P.C. dba Compass Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Cohort A: Elevated Risk Group (70% of cohort):

  • Age: Participant must be 50 years of age or older at the time of signing the Informed Consent Form (ICF).
  • Participants must meet at least one of the criteria below:
  • History of smoking at least 100 cigarettes in his or her lifetime
  • Documented genetic cancer predisposition, hereditary cancer syndrome, or meeting criteria for germline testing based on current NCCN guidelines
  • Personal history of invasive or hematologic malignancy, with definitive treatment completed greater than 3 years prior to enrollment. Adjuvant hormone therapy for cancer is permissible (ie may be ongoing within 3 years or at the time of enrollment).

Cohort B: Non-Elevated Risk Group (30% of cohort):

  • Age: Participant must be 50 years of age or older, at the time of signing the Informed Consent Form (ICF).
  • None of the conditions described in Cohort A, criteria 2a-c
  • For all participants, 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 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.
  • Definitive treatment for invasive or hematologic malignancy within the 3 years prior to expected enrollment date. Adjuvant hormone therapy for cancer is not an exclusion criterion.
  • Individuals who will not be able to comply with the protocol procedures.
  • Individuals who are not current patients at a participating center.
  • Previous or current participation in another GRAIL-sponsored study.
  • Previous or current employees or contractors of GRAIL.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Elevated Risk and Non-Elevated Risk Groups

Two cohorts:

  1. Elevated risk group (approximately 70% of the total enrollment) on the basis of history of smoking, documented genetic cancer predisposition, or personal history of invasive or hematologic malignancy.
  2. Non-elevated risk group (approximately 30% of the total enrollment) with none of the conditions listed in the Elevated Risk Group.
Device: Multi-Cancer Early Detection Test
Blood collection and multi-cancer early detection testing with return of results.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Per participant count of the number and types of diagnostic tests required to achieve diagnostic resolution following a "signal detected" multi-cancer early detection test result.
Time Frame: Until diagnostic resolution or 12 months, whichever occurs first
Until diagnostic resolution or 12 months, whichever occurs first
Per participant time required to achieve diagnostic resolution following a "signal detected" multi-cancer early detection test result.
Time Frame: Until diagnostic resolution or 12 months, whichever occurs first
Until diagnostic resolution or 12 months, whichever occurs first

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Positive Predictive Value defined as the proportion of participants with cancer diagnosis out of all participants with "signal detected" multi-cancer early detection test result.
Time Frame: Up to 12 months
Up to 12 months
Negative Predictive Value defined as the proportion of participants with no cancer diagnosis out of all participants with "signal not detected" results and completed EOS assessment.
Time Frame: Up to 12 months
Up to 12 months
Specificity defined as the proportion of participants with "signal not detected" results out of all participants with no cancer diagnosis and completed end of study (EOS) assessment.
Time Frame: Up to 12 months
Up to 12 months
Tissue of origin (TOO) accuracy defined as the proportion of correct TOO predictions in participants with determinate TOO returned by the multi-cancer early detection test and cancer diagnosis.
Time Frame: Up to 12 months
Up to 12 months
Perceptions of the multi-cancer early detection test result assessed by Adapted Multidimensional Impact of Cancer Risk Assessment (Adapted MICRA). Higher scores represent worse outcomes from 0-95.
Time Frame: Up to 12 months
Up to 12 months
Changes in health-related quality of life following the multi-cancer early detection test assessed by Short Form Health Survey (SF-12v2).
Time Frame: Up to 12 months
The SF-12v2 is a measure of health related quality of life. Higher values represent better health e.g. Physical Component Summary (PCS) range from 4.62 to 76.36 and Mental Component Summary (MCS) range from 1.32 to 79.48.
Up to 12 months
Changes in anxiety following the multi-cancer early detection test result: Patient-reported Outcome Measurement Information System (PROMIS) Anxiety.
Time Frame: Up to 12 months
Assessed by Patient-reported Outcome Measurement Information System (PROMIS) Anxiety. Range in score from 4 to 20 with higher scores indicate greater severity of anxiety.
Up to 12 months
Satisfaction with the multi-cancer early detection test: scores
Time Frame: Up to 12 months
Range in score from 0-100 with higher scores indicating higher satisfaction.
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GRAIL, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 12, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 5, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 2, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 27, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 25, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 22, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GRAIL-007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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