Assessment of the Implementation of an Investigational Multi-Cancer Early Detection Test Into Clinical Practice
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|ClinicalTrials.gov Identifier: NCT04241796|
Recruitment Status : Completed
First Posted : January 27, 2020
Last Update Posted : October 25, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Cancer||Device: Multi-Cancer Early Detection Test||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6662 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: Elevated Risk and Non-Elevated Risk Groups
Device: Multi-Cancer Early Detection Test
Blood collection and multi-cancer early detection testing with return of results.
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- 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.
- 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.
- 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.
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|Ages Eligible for Study:||50 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
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
- 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.
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
|United States, California|
|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, 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|
|Responsible Party:||GRAIL, LLC|
|Other Study ID Numbers:||
|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|
|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|