Clinical trial NCT05155605: PATHFINDER 2: a Multi-Cancer Early Detection Study
Official title: The PATHFINDER 2 Study: Evaluating the Safety and Performance of the GRAIL Multi-Cancer Early Detection Test in an Eligible Screening Population
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Early Detection of Cancer
Cancer
Keywords: multi-cancer early detection
cancer screening
circulating cell-free tumor DNA
MCED
Lead sponsor: GRAIL, Inc.
Sponsor class: INDUSTRY
First posted: 2021-12-13
Enrollment: 35885
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. 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).
2. 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.

   * Individuals with a diagnosis of non-metastatic basal cell carcinoma and squamous cell carcinoma of the skin are not excluded.
3. Prior/Concurrent Concomitant Therapy (Medications/Treatments):

   * Definitive treatment for invasive solid tumor or hematologic malignancy within the 3 years prior to expected enrollment date. Adjuvant hormone therapy for cancer (e.g. for breast or prostate cancer) is not an exclusion criterion.
4. Individuals who will not be able to comply with the protocol procedures.
5. Individuals who are not currently registered patients at a participating center.
6. Previous or current participation in another GRAIL-sponsored study. "Participation" is defined as having signed consent and provided a blood sample.
7. Previous or current employees or contractors of GRAIL.
8. Current pregnancy (by self-report of pregnancy status)

Primary outcomes:
measure: 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
measure: Test performance: diagnosis of invasive cancer, assessed by positive predictive value (PPV).
timeFrame: Up to 3 Years
measure: Test performance: diagnosis of invasive cancer, assessed by negative predictive value (NPV).
timeFrame: Up to 3 Years
measure: Test performance: diagnosis of invasive cancer, assessed by sensitivity.
timeFrame: Up to 3 Years
measure: Test performance: diagnosis of invasive cancer, assessed by specificity.
timeFrame: Up to 3 Years
measure: Test performance: diagnosis of invasive cancer, assessed by cancer signal origin (CSO) accuracy.
timeFrame: Up to 3 Years
measure: Test performance: diagnosis of invasive cancer, assessed by observed cancer detection rate (CDR).
timeFrame: Up to 3 Years
measure: Test performance: diagnosis of invasive cancer, assessed by number needed to screen to detect an invasive cancer (NNS).
timeFrame: Up to 3 Years
Secondary outcomes:
measure: Participant-reported anxiety resulting from use of the multi-cancer early detection (MCED) test assessed via questionnaire at various time points during the study.
timeFrame: Up to 3 Years
measure: Participant-reported intention to follow and use guideline recommended cancer screening procedures after use of the multi-cancer early detection (MCED) test assessed via questionnaire at various time points during the study.
timeFrame: Up to 3 Years
measure: Cancer detection rate of confirmatory PET-CT in participants for whom cancer signal origin directed workups do not result in diagnosis of cancer.
timeFrame: Up to 3 Years
measure: Number and type of diagnostic evaluations (imaging procedures, invasive procedures, laboratory test) by predicted cancer signal origin and outcome of diagnostic resolution.
timeFrame: Up to 3 Years
measure: Per-participant radiation exposure during diagnostic evaluation for test positive participants.
timeFrame: Up to 3 Years
measure: Accuracy of initial multi-cancer early detection (MCED) test result and cancer signal origin prediction, among the subset of participants with a research blood draw.
timeFrame: Up to 3 Years
measure: Participants-reported perceptions about the multi-cancer early detection (MCED) test including satisfaction with the MCED tests and attitudes towards subsequent MCED testing assessed via questionnaire at various time points during the study.
timeFrame: Up to 3 Years
Other outcomes:
Locations:
city: Auburn
country: United States
facility: Sutter Health
state: California
city: Davis
country: United States
facility: Sutter Health
state: California
city: Elk Grove
country: United States
facility: Sutter Health
state: California
city: Fairfield
country: United States
facility: Sutter Health
state: California
city: Irvine
country: United States
facility: HOAG Irvine
state: California
city: Irvine
country: United States
facility: HOAG Vivante Newport Mesa
state: California
city: Long Beach
country: United States
facility: Long Beach Memorial Medical Center
state: California
city: Modesto
country: United States
facility: Sutter Health
state: California
city: Newport Beach
country: United States
facility: HOAG Newport Beach
state: California
city: Palo Alto
country: United States
facility: Palo Alto Medical Foundation
state: California
city: Sacramento
country: United States
facility: Sutter Health
state: California
city: Santa Cruz
country: United States
facility: PAMF - Santa Cruz
state: California
city: Sunnyvale
country: United States
facility: PAMF - Sunnyvale
state: California
city: Englewood
country: United States
facility: Sarah Cannon Research Institute - Englewood Primary Care
state: Colorado
city: NW
country: United States
facility: Medstar Washington Hospital Center
state: District of Columbia
city: Pensacola
country: United States
facility: Woodlands Medical Specialists
state: Florida
city: Atlanta
country: United States
facility: Morehouse School of Medicine
state: Georgia
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Baton Rouge
country: United States
facility: Ochsner Grove
state: Louisiana
city: Lafayette
country: United States
facility: Ochsner Lafayette General
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Health
state: Louisiana
city: Annapolis
country: United States
facility: Maryland Oncology Hematology
state: Maryland
city: Clinton
country: United States
facility: Henry Ford Macomb
state: Michigan
city: Dearborn
country: United States
facility: Henry Ford Medical Center Ford Road
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Medical Center Harbortown
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Medical Center Detroit North West
state: Michigan
city: Sterling Heights
country: United States
facility: Henry Ford Medical Center Sterling Heights
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic - Cancer Center
state: Minnesota
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
city: Queens
country: United States
facility: Flushing Hospital Medical Center
state: New York
city: Queens
country: United States
facility: Jamaica Hospital Medical Center
state: New York
city: Asheville
country: United States
facility: Sarah Cannon Asheville Family Medicine
state: North Carolina
city: Durham
country: United States
facility: Duke University Health System
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma
state: Oklahoma
city: Bend
country: United States
facility: St. Charles Health System
state: Oregon
city: Coos Bay
country: United States
facility: Oregon Health & Science University Bay Area Hospital
state: Oregon
city: Portland
country: United States
facility: Oregon Health & Science University Knight Cancer Institute
state: Oregon
city: Salem
country: United States
facility: SALEM Health
state: Oregon
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Nashville
country: United States
facility: Sarah Cannon Research Institute - The Frist Clinic
state: Tennessee
city: Nashville
country: United States
facility: Sarah Cannon, Centennial Internal Medicine Continuity Clinic
state: Tennessee
city: Amarillo
country: United States
facility: Texas Oncology - West Texas
state: Texas
city: Austin
country: United States
facility: Sarah Cannon, Austin Diagnostic Clinic
state: Texas
city: Houston
country: United States
facility: Kelsey-Seybold Clinic Cypress Woods
state: Texas
city: Houston
country: United States
facility: Kelsey-Seybold Clinic Holcombe
state: Texas
city: Plano
country: United States
facility: Texas Oncology - Plano East
state: Texas
city: Plano
country: United States
facility: Texas Oncology - Plano West
state: Texas
city: San Antonio
country: United States
facility: University Texas Health San Antonio - Mays Cancer Center
state: Texas
city: Tyler
country: United States
facility: Texas Oncology - Tyler
state: Texas
city: Fairfax
country: United States
facility: Inova
state: Virginia
city: Norfolk
country: United States
facility: Eastern Virginia Medical School
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Vancouver
country: United States
facility: Northwest Cancer Specialists
state: Washington
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: GRAIL, Inc.
name: Celine Marquez, MD
role: STUDY_DIRECTOR
References: