PATHFINDER 2: A Multi-Cancer Early Detection Study

Cancer Clinical Trial

Official title:

The PATHFINDER 2 Study: Evaluating the Safety and Performance of the GRAIL Multi-Cancer Early Detection Test in an Eligible Screening Population

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05155605
• Other study ID #: GRAIL-012
• Status: Recruiting
• Phase: N/A
• Start date: December 8, 2021
• Est. completion date: December 31, 2027

Study information

• Verified date: March 2024
• Source: GRAIL, LLC
• Contact: GRAIL Customer Service
• Phone: 833-694-2553
• Email: customerservice[@]grail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35000
• Est. completion date: December 31, 2027
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cancer
• Early Detection of Cancer

Intervention

Device:
• Multi-Cancer Early Detection Test
Blood collection and multi-cancer early detection testing with return of results.

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario
United States	Texas Oncology - West Texas	Amarillo	Texas
United States	Maryland Oncology Hematology	Annapolis	Maryland
United States	Sarah Cannon Asheville Family Medicine	Asheville	North Carolina
United States	Morehouse School of Medicine	Atlanta	Georgia
United States	Sutter Health	Auburn	California
United States	Sarah Cannon, Austin Diagnostic Clinic	Austin	Texas
United States	Ochsner Grove	Baton Rouge	Louisiana
United States	St. Charles Health System	Bend	Oregon
United States	University of Illinois at Chicago	Chicago	Illinois
United States	Cleveland Clinic	Cleveland	Ohio
United States	Henry Ford Macomb	Clinton Township	Michigan
United States	Oregon Health & Science University Bay Area Hospital	Coos Bay	Oregon
United States	Texas Oncology - Dallas Presbyterian	Dallas	Texas
United States	Sutter Health	Davis	California
United States	Henry Ford Medical Center Ford Road	Dearborn	Michigan
United States	Henry Ford Health System	Detroit	Michigan
United States	Henry Ford Medical Center Detroit North West	Detroit	Michigan
United States	Henry Ford Medical Center Harbortown	Detroit	Michigan
United States	Duke University Health System	Durham	North Carolina
United States	Sutter Health	Elk Grove	California
United States	Sarah Cannon Research Institute - Englewood Primary Care	Englewood	Colorado
United States	Inova	Fairfax	Virginia
United States	Sutter Health	Fairfield	California
United States	Texas Oncology, P.A	Flower Mound	Texas
United States	Texas Oncology, P.A.	Fort Worth	Texas
United States	Kelsey-Seybold Clinic Cypress Woods	Houston	Texas
United States	Kelsey-Seybold Clinic Holcombe	Houston	Texas
United States	HOAG Irvine	Irvine	California
United States	HOAG Vivante Newport Mesa	Irvine	California
United States	Ochsner Lafayette General	Lafayette	Louisiana
United States	Long Beach Memorial Medical Center	Long Beach	California
United States	Sutter Health	Modesto	California
United States	Sarah Cannon Research Institute - The Frist Clinic	Nashville	Tennessee
United States	Sarah Cannon, Centennial Internal Medicine Continuity Clinic	Nashville	Tennessee
United States	Ochsner Health	New Orleans	Louisiana
United States	Weill Cornell Medicine	New York	New York
United States	HOAG Newport Beach	Newport Beach	California
United States	Eastern Virginia Medical School	Norfolk	Virginia
United States	University of Oklahoma	Oklahoma City	Oklahoma
United States	Palo Alto Medical Foundation	Palo Alto	California
United States	Woodlands Medical Specialists	Pensacola	Florida
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Texas Oncology - Plano East	Plano	Texas
United States	Texas Oncology - Plano West	Plano	Texas
United States	Oregon Health & Science University Knight Cancer Institute	Portland	Oregon
United States	Flushing Hospital Medical Center	Queens	New York
United States	Jamaica Hospital Medical Center	Queens	New York
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Mayo Clinic - Cancer Center	Rochester	Minnesota
United States	Sutter Health	Sacramento	California
United States	SALEM Health	Salem	Oregon
United States	PAMF - Santa Cruz	Santa Cruz	California
United States	Henry Ford Medical Center Sterling Heights	Sterling Heights	Michigan
United States	PAMF - Sunnyvale	Sunnyvale	California
United States	Texas Oncology - Tyler	Tyler	Texas
United States	Northwest Cancer Specialists	Vancouver	Washington
United States	Medstar Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
GRAIL, LLC

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Test performance: diagnosis of invasive cancer, assessed by positive predictive value (PPV).		Up to 3 Years
Primary	Test performance: diagnosis of invasive cancer, assessed by negative predictive value (NPV).		Up to 3 Years
Primary	Test performance: diagnosis of invasive cancer, assessed by sensitivity.		Up to 3 Years
Primary	Test performance: diagnosis of invasive cancer, assessed by specificity.		Up to 3 Years
Primary	Test performance: diagnosis of invasive cancer, assessed by cancer signal origin (CSO) accuracy.		Up to 3 Years
Primary	Test performance: diagnosis of invasive cancer, assessed by observed cancer detection rate (CDR).		Up to 3 Years
Primary	Test performance: diagnosis of invasive cancer, assessed by number needed to screen to detect an invasive cancer (NNS).		Up to 3 Years
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Per-participant radiation exposure during diagnostic evaluation for test positive participants.		Up to 3 Years
Secondary	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
Secondary	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