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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04241796
Recruitment Status : Completed
First Posted : January 27, 2020
Last Update Posted : October 25, 2022
Sponsor:
Information provided by (Responsible Party):
GRAIL, LLC

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Cancer Device: Multi-Cancer Early Detection Test Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6662 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: The PATHFINDER Study: Assessment of the Implementation of an Investigational Multi-Cancer Early Detection Test Into Clinical Practice
Actual Study Start Date : December 12, 2019
Actual Primary Completion Date : December 1, 2021
Actual Study Completion Date : January 5, 2022
Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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.

  7. 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.

  8. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04241796


Locations
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United States, California
Sutter Health
Roseville, California, United States, 95661
United States, Florida
Woodlands Medical Specialists, PA
Pensacola, Florida, United States, 32503
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Minnesota
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Oregon
Willamette Valley Cancer Institute
Eugene, Oregon, United States, 97401
Oregon Health & Science University
Portland, Oregon, United States, 97201
United States, Texas
Texas Oncology, PA (West TXO)
Amarillo, Texas, United States, 79106
United States, Utah
Intermountain Healthcare Research
Saint George, Utah, United States, 84790
United States, Virginia
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States, 22031
United States, Washington
Northwest Cancer Specialists, P.C. dba Compass Oncology
Vancouver, Washington, United States, 98684
Sponsors and Collaborators
GRAIL, LLC
More Information
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Responsible Party: GRAIL, LLC
ClinicalTrials.gov Identifier: NCT04241796    
Other Study ID Numbers: GRAIL-007
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: October 25, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes