PATHFINDER 2: a Multi-Cancer Early Detection Study

Not Applicable

Active, not recruiting

• Conditions: Cancer; Early Detection of Cancer
• Interventions: Device: Multi-Cancer Early Detection Test

• Registration Number: NCT05155605
• Lead Sponsor: GRAIL, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-16
• Study First Submitted QC: 2021-11-30
• Study Start: 2021-12-08
• Study First Posted: 2021-12-13
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-24
• Last Update Posted: 2024-12-30
• Primary Completion: 2026-02-28
• Study Completion: 2028-04-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 35885

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Participants 50 years of age or older	Multi-Cancer Early Detection Test	The study will aim to enroll a diverse participant population generally representative of the US population with respect to race, ethnicity, and sex. The target age categories of 60-69 years and 70-79 years will be enriched to increase the number of cancer events that are observed during the study.

Primary Outcome Measures

Name	Time	Method
Test performance: diagnosis of invasive cancer, assessed by negative predictive value (NPV).	Up to 3 Years
Test performance: diagnosis of invasive cancer, assessed by specificity.	Up to 3 Years
Test performance: diagnosis of invasive cancer, assessed by cancer signal origin (CSO) accuracy.	Up to 3 Years
Test performance: diagnosis of invasive cancer, assessed by number needed to screen to detect an invasive cancer (NNS).	Up to 3 Years
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).	Up to 3 Years
Test performance: diagnosis of invasive cancer, assessed by positive predictive value (PPV).	Up to 3 Years
Test performance: diagnosis of invasive cancer, assessed by sensitivity.	Up to 3 Years
Test performance: diagnosis of invasive cancer, assessed by observed cancer detection rate (CDR).	Up to 3 Years

Secondary Outcome Measures

Name	Time	Method
Participant-reported anxiety resulting from use of the multi-cancer early detection (MCED) test assessed via questionnaire at various time points during the study.	Up to 3 Years
Cancer detection rate of confirmatory PET-CT in participants for whom cancer signal origin directed workups do not result in diagnosis of cancer.	Up to 3 Years
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.	Up to 3 Years
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.	Up to 3 Years
Number and type of diagnostic evaluations (imaging procedures, invasive procedures, laboratory test) by predicted cancer signal origin and outcome of diagnostic resolution.	Up to 3 Years
Per-participant radiation exposure during diagnostic evaluation for test positive participants.	Up to 3 Years
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.	Up to 3 Years

Trial Locations

Locations (51)

Sutter Health; 🇺🇸 Sacramento, California, United States

HOAG Irvine; 🇺🇸 Irvine, California, United States

HOAG Vivante Newport Mesa; 🇺🇸 Irvine, California, United States

Long Beach Memorial Medical Center; 🇺🇸 Long Beach, California, United States

HOAG Newport Beach; 🇺🇸 Newport Beach, California, United States

Palo Alto Medical Foundation; 🇺🇸 Palo Alto, California, United States

PAMF - Santa Cruz; 🇺🇸 Santa Cruz, California, United States

PAMF - Sunnyvale; 🇺🇸 Sunnyvale, California, United States

Sarah Cannon Research Institute - Englewood Primary Care; 🇺🇸 Englewood, Colorado, United States

Medstar Washington Hospital Center; 🇺🇸 NW, District of Columbia, United States

Woodlands Medical Specialists; 🇺🇸 Pensacola, Florida, United States

Morehouse School of Medicine; 🇺🇸 Atlanta, Georgia, United States

University of Illinois at Chicago; 🇺🇸 Chicago, Illinois, United States

Ochsner Grove; 🇺🇸 Baton Rouge, Louisiana, United States

Ochsner Lafayette General; 🇺🇸 Lafayette, Louisiana, United States

Ochsner Health; 🇺🇸 New Orleans, Louisiana, United States

Maryland Oncology Hematology; 🇺🇸 Annapolis, Maryland, United States

Henry Ford Macomb; 🇺🇸 Clinton, Michigan, United States

Henry Ford Medical Center Ford Road; 🇺🇸 Dearborn, Michigan, United States

Henry Ford Health System; 🇺🇸 Detroit, Michigan, United States

Henry Ford Medical Center Harbortown; 🇺🇸 Detroit, Michigan, United States

Henry Ford Medical Center Detroit North West; 🇺🇸 Detroit, Michigan, United States

Henry Ford Medical Center Sterling Heights; 🇺🇸 Sterling Heights, Michigan, United States

Mayo Clinic - Cancer Center; 🇺🇸 Rochester, Minnesota, United States

Weill Cornell Medicine; 🇺🇸 New York, New York, United States

Flushing Hospital Medical Center; 🇺🇸 Queens, New York, United States

Jamaica Hospital Medical Center; 🇺🇸 Queens, New York, United States

Sarah Cannon Asheville Family Medicine; 🇺🇸 Asheville, North Carolina, United States

Duke University Health System; 🇺🇸 Durham, North Carolina, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

University of Oklahoma; 🇺🇸 Oklahoma City, Oklahoma, United States

St. Charles Health System; 🇺🇸 Bend, Oregon, United States

Oregon Health & Science University Bay Area Hospital; 🇺🇸 Coos Bay, Oregon, United States

Oregon Health & Science University Knight Cancer Institute; 🇺🇸 Portland, Oregon, United States

SALEM Health; 🇺🇸 Salem, Oregon, United States

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

Sarah Cannon Research Institute - The Frist Clinic; 🇺🇸 Nashville, Tennessee, United States

Sarah Cannon, Centennial Internal Medicine Continuity Clinic; 🇺🇸 Nashville, Tennessee, United States

Texas Oncology - West Texas; 🇺🇸 Amarillo, Texas, United States

Sarah Cannon, Austin Diagnostic Clinic; 🇺🇸 Austin, Texas, United States

Kelsey-Seybold Clinic Cypress Woods; 🇺🇸 Houston, Texas, United States

Kelsey-Seybold Clinic Holcombe; 🇺🇸 Houston, Texas, United States

Texas Oncology - Plano East; 🇺🇸 Plano, Texas, United States

Texas Oncology - Plano West; 🇺🇸 Plano, Texas, United States

University Texas Health San Antonio - Mays Cancer Center; 🇺🇸 San Antonio, Texas, United States

Texas Oncology - Tyler; 🇺🇸 Tyler, Texas, United States

Inova; 🇺🇸 Fairfax, Virginia, United States

Eastern Virginia Medical School; 🇺🇸 Norfolk, Virginia, United States

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States

Northwest Cancer Specialists; 🇺🇸 Vancouver, Washington, United States

University Health Network; 🇨🇦 Toronto, Ontario, Canada