Galleri in the Medicare Population

Description

This multi-center comparative prospective cohort study is designed to assess the real world clinical impact, including safety and test performance, of Galleri®, a blood-based multi-cancer early detection (MCED) test. The study will seek to enroll approximately 20% of the study participants from under-represented minority populations (e.g., racial / ethnic minority groups, socioeconomically disadvantaged populations, rural populations).

Conditions

Cancer

Study Overview

Study Details

Study overview

This multi-center comparative prospective cohort study is designed to assess the real world clinical impact, including safety and test performance, of Galleri®, a blood-based multi-cancer early detection (MCED) test. The study will seek to enroll approximately 20% of the study participants from under-represented minority populations (e.g., racial / ethnic minority groups, socioeconomically disadvantaged populations, rural populations).

REACH Study: Real-world Evidence to Advance Multi-Cancer Early Detection Health Equity

Galleri in the Medicare Population

Condition
Cancer
Intervention / Treatment

-

Contacts and Locations

Indianapolis

Community Health Network, Indianapolis, Indiana, United States, 46256

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Aged ≥50 years with Medicare coverage,
  • * Eligible to receive the Galleri test, based on a determination by the study investigator or designee that the test is clinically appropriate,
  • * Capable of giving informed consent that is legally effective (consent provided by a legally authorized representative is not permitted in this protocol), and
  • * Able to comprehend and respond to questions in participant questionnaires. Comprehension level is determined by the study investigator or designee.
  • * Aged ≥ 50 years with Medicare coverage,
  • * Have had ≥ 1 UC visit
  • * Having had a previous Galleri test not associated with this study.
  • * Undergoing clinical evaluation for symptoms suspicious for cancer.
  • * 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 (i.e., for breast or prostate cancer) is not an exclusion criterion.
  • * Current pregnancy
  • * 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 employees or contractors of GRAIL.
  • * 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.
  • * Current pregnancy.

Ages Eligible for Study

50 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

GRAIL, Inc.,

Study Record Dates

2030-09