PATHFINDER 2: A Multi-Cancer Early Detection Study

Sponsor
GRAIL, LLC (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05155605
Collaborator
(none)
20,000
27
1
55.7
740.7
13.3

Study Details

Study Description

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 20,000 participants as defined by eligibility criteria over an anticipated enrollment period of approximately 18 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Multi-Cancer Early Detection Test
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20000 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
The PATHFINDER 2 Study: Evaluating the Safety and Performance of the GRAIL Multi-Cancer Early Detection Test in an Eligible Screening Population
Actual Study Start Date :
Dec 8, 2021
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Jul 30, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Participants 50 years of age or older

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.

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

Outcome Measures

Primary Outcome Measures

  1. 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]

  2. Test performance: diagnosis of invasive cancer, assessed by positive predictive value (PPV). [Up to 3 Years]

  3. Test performance: diagnosis of invasive cancer, assessed by negative predictive value (NPV). [Up to 3 Years]

  4. Test performance: diagnosis of invasive cancer, assessed by sensitivity. [Up to 3 Years]

  5. Test performance: diagnosis of invasive cancer, assessed by specificity. [Up to 3 Years]

  6. Test performance: diagnosis of invasive cancer, assessed by cancer signal origin (CSO) accuracy. [Up to 3 Years]

  7. Test performance: diagnosis of invasive cancer, assessed by observed cancer detection rate (CDR). [Up to 3 Years]

  8. Test performance: diagnosis of invasive cancer, assessed by number needed to screen to detect an invasive cancer (NNS). [Up to 3 Years]

Secondary Outcome Measures

  1. 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]

  2. 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]

  3. 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]

  4. 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]

  5. Per-participant radiation exposure during diagnostic evaluation for test positive participants. [Up to 3 Years]

  6. 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]

  7. 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.
  1. 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.
  1. Individuals who will not be able to comply with the protocol procedures.

  2. Individuals who are not currently registered patients at a participating center.

  3. Previous or current participation in another GRAIL-sponsored study. "Participation" is defined as having signed consent and provided a blood sample.

  4. Previous or current employees or contractors of GRAIL.

  5. Current pregnancy (by self-report of pregnancy status)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sutter Health Auburn California United States 95602
2 Sutter Health Davis California United States 95616
3 Sutter Health Elk Grove California United States 95758
4 Sutter Health Fairfield California United States 94534
5 Sutter Health Modesto California United States 95355
6 Sutter Health Sacramento California United States 95816
7 Sarah Cannon Research Institute - Englewood Primary Care Englewood Colorado United States 80113
8 Woodlands Medical Specialists Pensacola Florida United States 32503
9 Ochsner Health New Orleans Louisiana United States 70127
10 Maryland Oncology Hematology Annapolis Maryland United States 21401
11 Henry Ford Macomb Clinton Township Michigan United States 48038
12 Henry Ford Medical Center Ford Road Dearborn Michigan United States 48126
13 Henry Ford Health System Detroit Michigan United States 48202
14 Henry Ford Medical Center Harbortown Detroit Michigan United States 48207
15 Henry Ford Medical Center Detroit North West Detroit Michigan United States 48235
16 Henry Ford Medical Center Sterling Heights Sterling Heights Michigan United States 48310
17 Mayo Clinic - Cancer Center Rochester Minnesota United States 55905
18 Cleveland Clinic Cleveland Ohio United States 44195
19 Oregon Health & Science University Bay Area Hospital Coos Bay Oregon United States 97420
20 Oregon Health & Science University Knight Cancer Institute Portland Oregon United States 97201
21 Sarah Cannon Research Institute - The Frist Clinic Nashville Tennessee United States 37203
22 Texas Oncology - West Texas Amarillo Texas United States 79106
23 Texas Oncology - Dallas Presbyterian Dallas Texas United States 75231
24 Texas Oncology - Plano East Plano Texas United States 75075
25 Texas Oncology - Plano West Plano Texas United States 75093
26 Texas Oncology - Tyler Tyler Texas United States 75702
27 Northwest Cancer Specialists Vancouver Washington United States 98684

Sponsors and Collaborators

  • GRAIL, LLC

Investigators

  • Study Director: Eric Fung, MD, PhD, GRAIL, LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
GRAIL, LLC
ClinicalTrials.gov Identifier:
NCT05155605
Other Study ID Numbers:
  • GRAIL-012
First Posted:
Dec 13, 2021
Last Update Posted:
Aug 5, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Keywords provided by GRAIL, LLC

Study Results

No Results Posted as of Aug 5, 2022