A Study to Assess the Implementation of an Investigational Multi-Cancer Early Detection Test Into Clinical Practice

Overview

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.

 

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:

  • 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

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 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 Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Minetta Liu, M.D.

Open for enrollment

Contact information:

Susan Sawinski B.S.

(507) 774-8359

Sawinski.Susan@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions