PATHFINDER 2: A Multi-Cancer Early Detection Study
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 21-009209
NCT ID: NCT05155605
Sponsor Protocol Number: GRAIL-012
About this study
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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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)
Eligibility last updated6/7/22. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
More information
Publications
Publications are currently not available