PATHFINDER 2: a Multi-Cancer Early Detection Study
- Conditions
- CancerEarly Detection of Cancer
- 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
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 35885
- Participants must be at least 50 years of age, inclusive, at the time of signing the Informed Consent Form (ICF).
- Participants must be capable of giving signed and legally effective informed consent
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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).
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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.
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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.
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Individuals who will not be able to comply with the protocol procedures.
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Individuals who are not currently registered patients at a participating center.
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Previous or current participation in another GRAIL-sponsored study. "Participation" is defined as having signed consent and provided a blood sample.
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Previous or current employees or contractors of GRAIL.
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Current pregnancy (by self-report of pregnancy status)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- 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
Scroll for more (41 remaining)Sutter Health🇺🇸Sacramento, California, United States