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Active, Not Recruiting

NCT Number: NCT05155605

PATHFINDER 2: A Multi-Cancer Early Detection Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Early Detection of Cancer Cancer Neoplasms

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Health Network, Toronto, Ontario, Canada

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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).
  • 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.
  • 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.
  • Individuals who will not be able to comply with the protocol procedures.
  • Individuals who are not currently registered patients at a participating center.
  • Previous or current participation in another GRAIL-sponsored study. "Participation" is defined as having signed consent and provided a blood sample.
  • Previous or current employees or contractors of GRAIL.
  • Current pregnancy (by self-report of pregnancy status)

Treatment and study plan

Multi-Cancer Early Detection Test

Device

Blood collection and multi-cancer early detection testing with return of results.

Primary outcomes

  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).

    Time frame: Up to 3 Years

  2. Test performance: diagnosis of invasive cancer, assessed by positive predictive value (PPV).

    Time frame: Up to 3 Years

  3. Test performance: diagnosis of invasive cancer, assessed by negative predictive value (NPV).

    Time frame: Up to 3 Years

  4. Test performance: diagnosis of invasive cancer, assessed by sensitivity.

    Time frame: Up to 3 Years

  5. Test performance: diagnosis of invasive cancer, assessed by specificity.

    Time frame: Up to 3 Years

  6. Test performance: diagnosis of invasive cancer, assessed by cancer signal origin (CSO) accuracy.

    Time frame: Up to 3 Years

  7. Test performance: diagnosis of invasive cancer, assessed by observed cancer detection rate (CDR).

    Time frame: Up to 3 Years

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

    Time frame: Up to 3 Years

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: Up to 3 Years

  5. Per-participant radiation exposure during diagnostic evaluation for test positive participants.

    Time frame: 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.

    Time frame: 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.

    Time frame: Up to 3 Years

Sponsors and collaborators

Lead sponsor

GRAIL, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2028
First posted
Dec 13, 2021
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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