A Study to Assess the Implementation of an Investigational Multi-Cancer Early Detection Test Into Clinical Practice
Tab Title Description
Describes 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.
- Rochester, Minnesota: 19-011029
NCT ID: NCT04241796
Sponsor Protocol Number: GRAIL-007
About this study
The purpose of this study is to evaluate an investigational, multi-cancer early detect test developed by Grail, Inc. with the results returned to a study investigator.
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.
- Cohort A: Elevated Risk Group (70% of cohort):
- Age: Participant must be 50 years of age or older at the time of signing the Informed Consent Form (ICF).
Participants must meet at least one of the criteria below:
- History of smoking at least 100 cigarettes in his or her lifetime.
- Documented genetic cancer predisposition, hereditary cancer syndrome, or meeting criteria for germline testing based on current NCCN guidelines.
- Personal history of invasive or hematologic malignancy, with definitive treatment completed greater than 3 years prior to enrollment. Adjuvant hormone therapy for cancer is permissible (i.e., may be ongoing within 3 years or at the time of enrollment).
- Cohort B: Non-Elevated Risk Group (30% of cohort):
- Age: Participant must be 50 years of age or older at the time of signing the Informed Consent Form (ICF);
- None of the conditions described in Cohort A.
- For all participants, capable of giving signed and legally effective informed consent
- 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 or hematologic malignancy, diagnosed within the 3 years prior to expected enrollment date.
- Definitive treatment for invasive or hematologic malignancy within the 3 years prior to expected enrollment date. Adjuvant hormone therapy for cancer is not an exclusion criterion.
- Individuals who will not be able to comply with the protocol procedures.
- Individuals who are not current patients at a participating center.
- Previous or current participation in another GRAIL-sponsored study.
- Previous or current employees or contractors of GRAIL.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
|Mayo Clinic Location
Mayo Clinic principal investigator
Minetta Liu, M.D.
Open for enrollment
Susan Sawinski B.S.
Publications are currently not available
Study Results Summary
Not yet available
Supplemental Study Information
Not yet available